03 MAR 2022 Russia/Ukraine conflict business continuity statement:
Associates of Cape Cod, Inc. (ACC) confirms that the Russia/Ukraine conflict currently has no impact on ACC product manufacturing or service provision, and ACC does not source raw materials or critical items from that geographical region.

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Careers

Logistics Technician 1

Description: Work as part of a team where needed in one of the 4 Logistics Departments. To include controlling of inventory in the Finished goods and Raw and WIP material warehouses, receiving incoming packages/shipments, labeling of product, packaging final product for sale, and fulfillment of customers’ orders.

This position will be primarily working in our Packaging department but may be called upon to work in Shipping, Receiving or our Labeling departments

This is fulltime entry level position, experience is a plus but not required, will train the right candidate.

General Responsibilities:

    Shipping;
  • Fulfillment of all Customers orders
  • Preparation of all outgoing shipments including documentation for those shipments
  • Control of all “Finished Released” product
    Receiving;
  • Receives/stores all materials for ACC use
  • Performs all necessary receiving transaction within Data Management System (DMS). Confirms accuracy of receipt against ACC documentation/Purchase Order
  • Receipt of Testing Services samples
  • Fulfills and completes transactions of all raw material in-house material requisitions
  • Control of all RAW inventory
    Kitting/packaging;
  • Assists Kitting Department as needed, in the manufacturing/packaging of finished product to be sold to customers
  • All necessary DMS transactions for the above packaging process
  • Control of all WIP material
    Labeling;
  • Assists in the labeling department as needed, labeling finished products as well as in-process material
  • Control of all Label WIP material
    Additional;
  • In addition to the above tasks, assisting in weekly cycle counts in all areas
  • Absentee coverage in all areas

Knowledge and Skill Requirements:

  • Detail oriented
  • Strong organizational skills
  • Good communications skills
  • Working computer knowledge
  • Ability to multitask

Education and Experience:

  • High school diploma or equivalent
  • Detail oriented
  • Strong organizational skills
  • Good communications skills
  • Working computer knowledge
  • IATA/DOT knowledge a plus

General Competencies:

  • Able to work independently or as part of a team within a fast paced fast-paced deadline environment
  • Ability to multitask
  • Ability to be flexible and shift direction easily
  • Ability to prioritize
  • Ability to read and follow direction

Physical Requirements:

  • Ability to lift at least 25 lbs.
  • Ability to do repetitive jobs/movements
  • Ability to work on your feet for extended periods of time

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Logistics Technician 1 here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High school diploma or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Medical Technologist - Beacon Diagnostic® Lab

Purpose: Perform Fungitell® testing on samples received in Beacon Diagnostic® Laboratory (BDL) based on standard operating procedures to comply with CLIA, HIPPA, HITECH and other applicable national requirements.

General Responsibilities:

  • Responsible for daily activities as they pertain to the Beacon Diagnostic® Laboratory, which entail, but are not limited to, accessioning patient samples , analyzing patient samples, reviewing data (except for NY DOH), producing reports, and invoicing customers
  • Be familiar with and follow the quality policy for ACC
  • Be familiar and follow the ACC safety policy
  • Be familiar with and follow the standard operating procedures (SOP) for BDL and ACC
  • Report results to clients following BDL SOP's
  • Interact with clients to determine their testing needs
  • Interact with clients when a sample needs to be retested
  • Proper documentation of interactions with clients
  • Maintain compliance with HIPPA and other national requirements
  • Ensure that the Fungitell® test method and standard operating procedures used to test samples from Beacon Diagnostic laboratory are current and in compliance with CLIA and other applicable guidance
  • Monitor compliance of the established policies and procedures to determine where improvements are needed and implement appropriate corrective and preventative actions
  • Utilize calibrated/certified equipment and instrumentation – notify responsible departments if equipment/instrumentation is out of calibration/certification
  • Identify samples for disposal and follow correct/appropriate disposal procedure
  • Use appropriate procedures for laboratory and biohazard waste
  • Attend training as scheduled by ACC
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Excellent knowledge of CLIA, state regulations, HIPPA, and biosafety/bloodborne pathogen regulations
  • Ability to work effectively with customers and all levels of internal personnel
  • Detail oriented and excellent organizational skills
  • Able to work in a fast paced team environment
  • Excellent oral and written communications skills
  • Required to pass pipetting proficiency training and certification course
  • Other – Hepatitis B vaccination

Education and Experience:

  • A minimum of a Bachelor's Degree in a scientific or health care discipline or equivalent combination of experience and/or education required
  • Must have at least two years of experience in clinical diagnostics

General Competencies:

  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Information organized and accessible, maintains efficient work space, manages time well
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand, and occasionally walk. Constantly use hands to finger, handle or feel. Frequently reach with hands or arms. Constantly talk or listen. Lift 1-10 lb., 1-33% of the time. Carry 1-10 lb., 1-33% of the time. Constantly exposed to fumes or airborne particles. Constantly exposed to toxic or caustic chemicals. Frequently exposed to vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Medical Technologist - Beacon Diagnostic Lab here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Fixed Asset Accountant

Purpose: Assists the Finance Director as a business partner responsible for fixed asset recording, valuation, accounting, timely capitalization and reporting of the company's fixed assets.

General Responsibilities:

  • Create and monitor improved system of controls, procedures and forms for recordation of fixed assets
  • Recommend any updates to accounting policies related to fixed assets
  • Develop improved processes to record acquisitions and dispositions of fixed assets
  • Track compilation of project costs into fixed asset accounts timely and accurately
  • Reconcile subledger and general ledger asset and depreciation balances
  • Investigate the potential obsolescence of fixed assets
  • Conduct periodic impairment reviews of intangible assets
  • Conduct physical counts and identification of fixed assets
  • Prepare audit schedules relating to fixed assets and assist auditors as necessary
  • Prepares journal entries, reports and adhoc requests
  • Conducts analyses, provides consulting, and makes recommendations
  • Actively support budget preparation, forecasts and analysis

Knowledge and Skill Requirements:

  • Fixed Asset Accounting Process
  • Internal Control design/improvement
  • Strong Excel Skills
  • Biopharma industry experience a plus
  • Microsoft Dynamics Great Plains a plus
  • Supports Y/E audit
  • Account reconciliation and control

Education and Experience:

  • +3 years Fixed Asset Accounting experience
  • Bachelor's Degree in Accounting/Finance, or equivalent in experience

General Competencies:

  • Reliability, integrity and commitment
  • Driven, detail oriented, creative thinker
  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Excellent communication skills (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, manages time well
  • Strives to eliminate errors, assess root cause and prevent recurrence
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Fixed Asset Accountant here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Cost Accountant

Purpose: Assists the Finance Director as a business partner in assessing business expenses, supporting optimized budget plans, developing, updating and analyzing cost standards and variances. Performing account reconciliations.

General Responsibilities:

  • Strong analytical skills and business judgment to provide general financial support to the business
  • Collecting and analyzing data about operational/manufacturing costs
  • Develop, update, and analyze Inventory cost standards
  • Indirect support of implementation and maintenance of ERP system
  • Preparation of Account Reconciliations
  • Cycle Count Internal Controls process design
  • Prepares journal entries, reports and adhoc requests
  • Conducts analyses, provides consulting, and makes recommendations
  • Actively support budget preparation, forecasts and analysis to evaluate and predict business performance
  • Support implementation of and adherence to corporate internal control standards

Knowledge and Skill Requirements:

  • Inventory/Manufacturing/Cost Accounting
  • Internal Control design/improvement
  • Strong Excel Skills
  • Multiple Currency experience a plus
  • Biopharma industry experience a plus
  • Microsoft Dynamics Great Plains a plus
  • Supports Y/E physical inventories and reconciliation
  • Account reconciliation and control

Education and Experience:

  • +3 years Cost Accounting experience
  • Experience working within ERP environment
  • Bachelor's Degree in Accounting/Finance, or equivalent in experience

General Competencies:

  • Reliability, integrity and commitment
  • Adapts to change, open to new ideas and responsibilities
  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Excellent communication skills (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual
  • Offers feedback, coach’s employees appropriately, rewards employees wisely, takes mentoring role, challenges and develops employees, offers opportunity
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, manages time well
  • Strives to eliminate errors, assess root cause and prevent recurrence
  • Meticulous, attention to detail, willing to research details & facts through hands-on approach
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Cost Accountant here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Temporary Laboratory Technician

Purpose: ASSOCIATES OF CAPE COD, INC. seeks full-time temporary workers to collect and process blood cells from horseshoe crabs to make LAL - a test for a bacterial toxin. Applicants must be hard working, careful, team players with a positive attitude. Work will last from approximately May - Mid August with a limited number of positions going into the holidays. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to Horseshoe Crab bleeding and processing

General Responsibilities:

  • Receiving crabs and unloading barrels of crabs from trucks
  • Bleeding crabs, initial cell processing, and operation of centrifuges
  • Washing and preparing all bleed related glassware
  • Assisting with preparation of Production glassware
  • Cleaning all bleed related rooms
  • Other duties as assigned by supervisor

Knowledge and Skill Requirements:

  • English language skills
  • Able to lift up to 25 lbs.

General Competencies:

  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Information organized and accessible, maintains efficient work space, manages time well
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities, to improve product/services; compliant with quality system requirements
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

  • Occasionally sit. Constantly stand, frequently walk. Constantly use hands to finger, handle or feel.
  • Frequently reach with hands or arms. Occasionally climb or balance. Constantly talk or hear. Occasionally taste or smell. Lift 26 to 50 lbs, 1-33% of the time. Carry 11-25 lbs, 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). Occasionally work near moving mechanical parts. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Temporary Laboratory Technician here.

In your cover letter please answer the following:

  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Fungitell® Technical Sales Specialist, Clinical Diagnostics

Location: Position will be located in either Boston, Chicago, Minneapolis, LA or San Francisco

Purpose: The Fungitell® Technical Sales Specialist, Clinical Diagnostics is responsible for identifying, nurturing, and qualifying leads into customers, by selling the company’s clinical diagnostic products and services in the US territory to help US Market meet or exceed the revenue plan. The position will provide qualified leads to the Regional Manager Clinical Diagnostics, while also being expected to support current customer inquiries including, but not limited to, providing pricing quotes and technical support.

General Responsibilities:

  • Reports to Regional Manager, Clinical Diagnostics
  • Cold-call prospects that are generated by external and internal lead sources to create and deliver qualified opportunities
  • Ensure timely follow-up of leads by capturing and communicating comprehensive customer details, calls-to-action and project timelines
  • Ability to meet target call point quotas
  • Overcome objections of prospective customers
  • Emphasize product/service features and benefits, and prepare customer sales quotations
  • Develop sales opportunities by researching and identifying potential accounts
  • Penetrate all targeted accounts and radiate sales from within client base
  • Maintain and expand the company’s database of prospects
  • Set up and deliver sales presentations, product/service demonstrations, and other sales actions
  • Timely follow up on all sales activities
  • Yearly qualification to successfully perform Fungitell® Predicate and Fungitell STAT® assays
  • Yearly qualification to successfully perform installations, and calibrations of Fungitell STAT® to support Technical Service
  • Accompany Regional Manager to occasional on-site customer visits
  • Where necessary, support marketing efforts such as trade shows, exhibits, and other events
  • Travel up to 50% of the year
  • Assisting with or performing presentations and workshop instruction at company held training courses and customer specific training courses, as required
  • Perform instrument calibrations in assigned region
  • Operate within the company approved expense budget

Knowledge and Skill Requirements:

  • Experience and knowledge of principles and practices of Sales
  • Experience and knowledge of clinical diagnostics and contract clinical testing laboratory operations
  • Proven ability to achieve and exceed sales targets
  • Demonstrate good business judgment
  • Self-starter and able to work independently
  • Interpersonal skills to build rapport with clients, communicate clearly in challenging situations and satisfy customers with issues or concerns
  • Possess excellent oral and written communication skills in addition to being an effective communicator
  • Must be skillful in presentation with strong ability in conducting negotiations in a persuasive manner
  • Ability to educate and demonstrate on the use of company products and services to potential clients and customers
  • Knowledge of customer service principles
  • Knowledge of basic business principles
  • Good working knowledge of Microsoft Word, Excel and PowerPoint
  • The Technical Sales Representative will become familiar with Company policies and procedures and present a professional image as a Company ambassador
  • Stress tolerance
  • Goal oriented
  • Must have valid driver’s license

Education and Experience:

  • Minimum of a College degree, preferably in a life science or engineering discipline, or equivalent combination of experience and/or education required
  • Two years of sales experience in biotech, medical device or pharmaceutical industry with provide sales history of growth and success

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, promotes a positive image of the company, strives to solve issues raised by customers
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Knows product features, understands marketplace, shares expertise with others
  • Manages workload, works efficiently, meets goals and objectives
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:
Frequently sit, stand, walk and use hands to finger, handle or feel. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Constantly talk or listen. Lift 26-50 lbs 1-33% of the time. Carry 26-50 lbs 34-66% of the time. Occasionally exposed to outdoor weather conditions. Noise level is quiet to moderate for the work environment of this job.

Updated vaccinations including Influenza, MMR, and COVID 19 required and acceptable titer determination required for full disease panel (including hepatitis A, B and C) expected for a hospital sales environment.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Fungitell® Technical Sales Specialist, Clinical Diagnostics here.

In your cover letter please answer the following:

  • Have you completed the following level of education: College Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Engineering Technician

Purpose: To perform routine inspection and calibration of ACC’s and customer instruments using standard operating procedures, perform re-qualifications of critical Production equipment, and provide assistance to the Engineering team with entry of Change Controls, Document Revisions, Complaints, Quality Events, and Deviations into the Electronic Document Management System as required.

General Responsibilities:

  • Perform routine incoming inspection, calibration, and troubleshooting of instrumentation with various software applications used for endotoxin and glucan testing
  • Draft validation protocols, execute re-qualifications for Production equipment, and create reports for Engineering and other ACC staff review and use
  • Enter relevant information into the Electronic Document Management System in support of Change Control, Complaints, Deviations, Quality Events, and Document Revisions
  • Participate in product development and process improvement team activities as required with the application of Design Control requirements if needed
  • Accurately complete all documentation relating to SOPs, Engineering Studies, and Validations
  • Support Engineering Department with validation and investigation activities

Knowledge and Skill Requirements:

  • Detail oriented and excellent organizational skills
  • Excellent oral and written communication skills
  • Familiarity with calibration and validation terminology and practices
  • Hands-on ability to perform incoming inspections and calibrations of ACC instruments for internal/ external customers
  • Ability to work both independently and in a team environment
  • Excellent problem-solving skills
  • General knowledge of FDA cGMP and ISO 13485 requirements as related to manufacturing
  • Strong computer skills using Microsoft Office Word, Excel, and Outlook programs

Education and Experience:
Ideal candidate will have a minimum of an Associate’s Degree in an Engineering, Life Sciences, or Biomedical discipline with at least 2 years of experience in the medical device, pharmaceutical, or biotech manufacturing industry or equivalent and familiarity with general requirements of operating in a FDA cGMP & ISO13485 environment.

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Committed to finding solutions to problems, works well in a team environment
  • Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries. Manages workload, works efficiently, and meets goals and objectives
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
  • Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:
Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Lift 26 to 50 lbs. 1-33% of the time, Carry 26 to 50 lbs. 1-33% of the time. Quiet noise is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Enginering Technican here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate’s Degree in an Engineering, Life Sciences, or Biomedical discipline?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Application Developer

Purpose: This position is responsible for the configuration management, updating and developing of modification to internal business applications including but not limited to Microsoft Dynamic, Microsoft CRM and Microsoft Business Portal. This position will also be responsible for the maintenance and development of other custom business applications.

General Responsibilities:

  • Participate in defining the strategy and vision for our internal business applications
  • Development of new and enhancement of existing internal business applications
  • Develop and maintain integrations with other business applications including CRM and ERP
  • Collaborate with Usability and designers to develop workflows and application designs
  • Work closely with end users and management to ensure a clear understanding of the business requirements
  • Develop and document requirements, functional and technical specifications
  • Work to ensure high quality for releases of our internal applications

Knowledge and Skill Requirements:

  • Must have proven experience developing high quality code
  • Experience developing and designing applications for internal usage
  • Proficiency in VB.Net, ASP.Net, PHP, SQL and Dexterity desired
  • Experience developing web applications desired
  • Proven ability in mentoring other developers and a strong commitment to team growth

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries
  • Creative, offers new ideas, risk taker, amenable to change
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Strives to understand contributing factors, works to resolve complex situations
  • Manages workload, works efficiently, and meets goals and objectives
  • Monitors status of projects, thoroughly deals with project details, holds project owners accountable, and delivers clear, accurate depiction of status
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Education and Experience:

  • 5+ year’s development experience
  • A minimum of a BS in Computer Science or an equivalent combination of experience and/or education required
  • Good written and oral communications skills, strong attention to detail and willingness to follow directions and established procedures with minimal supervision

Physical Requirements:
Frequently sit and stand, occasionally walk. Frequently use hands to finger, handle, or feel. Frequently reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch, or crawl. Constantly talk or listen. Occasionally taste or smell. Lift 1-10 lbs. 1-33% of the time. Carry 1-10 lbs. 1-33% of the time. Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Moderate noise level is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Application Developer here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Systems Specialist

Purpose: Assure compliance to ACC policies and procedures and applicable external standards. Provide recommendations to teams as they work within the different Quality System Elements, such as Design Control and investigation activities within all Quality Systems. Participate in all quality system investigations as needed, and other duties as assigned.

General Responsibilities:

  • Review Quality System Events per procedure for clarity and completeness
  • Support/Participate in Quality Event investigations, and maintain Quality Event system
  • Support investigation, corrective/preventive action and implementation of Quality Management System process improvements
  • Support investigating and coordinating other quality system assignments (Complaints, CAPA’s, Deviations, audit findings etc.) in a timely manner
  • Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the Quality Department
  • Write, revise, and train on standard operating procedures for continuous improvement as assigned
  • Support MRB activities and maintenance of MRB agenda
  • Perform Quality Assurance review of quality records, reports and data
  • Perform Internal Quality System Audits as assigned
  • Perform Supplier Quality System Audits as assigned
  • Participate in FDA, ISO, Internal, Customer, audits as required
  • Perform customer, distributor, and internal requests for quality information (i.e. paper audits, general information)
  • Perform effectivity/follow up to ensure that CAPA’s and other QMS changes/updates are effective
  • Other duties as assigned, which may include, but are not limited to:
    • Department trending for reporting
    • Assist in supporting the Annual Product Review program to meet company deadlines
    • Support Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas
    • Perform training on Quality topics as needed
    • Ensure non-conforming material is handled when found, per the Management of Quality Events procedure

Knowledge and Skill Requirements:

  • Working knowledge of cGMP, ISO 13485, and other international standards
  • High attention to detail and excellent organizational skills
  • Able to work in a fast paced team environment
  • High degree of critical thinking skills
  • Excellent oral and written communication skills
  • Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint
  • Ability to work with others and teams to resolve quality issues and ability to work independently without supervision

Education and Experience:

  • A minimum of a Bachelor’s degree or equivalent combination of experience and/or education required
  • Must have previous QA/QC experience in a regulated environment

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:
Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to toxic or caustic chemicals.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Systems Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Document Control Associate

Purpose: Maintain Document Control systems and activities in compliance with ACC policies and procedures, QSRs and 13485.

General Responsibilities:

  • Maintain Document Control databases and logs such that they are up to date, efficient, and accurate at all times
  • Maintain and control archive storage locations such that they are kept up to date and organized for ease of retrieval of records, and in a manner that prevents damage and misuse
  • Data entry
  • Scan/file/log records for archival, including training records
  • Retrieve archived records upon request and maintain archive activity log
  • Enter lot information into the Labeling databases per procedures
  • Participate in the process for preparing records for offsite storage and retrieval of those records when needed
  • Participate in the process for Record Retention and shredding
  • Participate in preparing documents for use in a timely manner such as Production binders (PHR’s), in-process paperwork, kitting and packaging requests, etc
  • Participate in quarterly review activities for Level 0 Documents (regulatory standards, guidance’s, etc)
  • Scan and upload certificates of analysis and certificates of compliance for Customer Service and website
  • Complete all QMS and training activities in a timely manner
  • Support and prioritize all Document Control related activities and requests for records
  • Prepare for, support, and participate in customer, regulatory, and internal audits
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Working knowledge of cGMP, ISO 13485 and principles of document control
  • Detail oriented and excellent organizational skills
  • Ability to work in a fast paced team environment
  • Ability to work on multiple tasks and meet deadlines
  • Excellent oral and written communication skills
  • Proficiency in all office based software

Education and Experience:

  • A minimum of an Associates Degree or equivalent combination of experience and/or education required
  • Minimum of 1 years experience working in an FDA and/or ISO regulated environment or equivalent combination of experience and/or education required

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Information, organized and accessible, maintains efficient work space, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements

Physical Requirements:
Constantly sit, occasionally stand, frequently walk, occasionally use hands to finger, handle, or feel. Constantly reach with hands or arms, climb or balance, stoop or kneel, crouch or crawl. Constantly talk or listen. Lift 11-25 lbs 1-33% of the time. Carry 11-25lbs 1-33% of the time. Occasionally exposed to toxic or caustic chemicals. The work environment is typically quiet for this job.

Job Type: Part-time

To Apply:

Please submit a current resume and cover letter for Document Control Associate here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Inspector

Purpose: Work as part of the Quality Assurance Team to ensure the highest quality product in compliance with internal procedures, cGMP’s 21 CFR 820 and ISO 13485.

General Responsibilities:

  • Inspection of finished product to meet internal procedures and customer requirements
  • Level 1 and 2 inspection of raw materials per applicable material specifications
  • Write and revise procedures as necessary
  • Assist with audits (customer, FDA, and ISO) in the knowledge area of inspection activities
  • Ensure non-conforming material is handled per applicable procedure
  • Ensure quarantine areas are orderly and items are properly labeled to its status, when applicable
  • Ensure timely trending of inspection data
  • Product label verification per applicable procedures
  • Inspection of kits using ANSI/ASQZ1.4-2003 and applicable procedures
  • Quality assurance review of quality records (i.e. charts, and other associated quality records)
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Use of Microsoft Word, Excel and Microsoft Outlook
  • Experience in performing quality inspections.
  • Slight lifting may be required

Education and Experience:

  • High school diploma and two years inspection experience or the equivalent combination of experience combination of experience and/or education required

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Communicates well (written and verbal)
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Physical Requirements:
Occasionally sit, constantly stand and walk, constantly use hands to finger, handle, or feel. Constantly reach with hands or arms, frequently climb or balance, occasionally stoop, kneel, crouch, or crawl. Constantly talk or listen, occasionally taste or smell. Lift 11 to 25 lbs. 1-33% of the time, carry 11to 25 lbs, 1-33% of the time. Occasionally exposed to working near moving mechanical parts. Frequently exposed to fumes or airborne particles or toxic or caustic chemicals. Moderate noise is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Inspector here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School diploma?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Associate Manager, Facilities

Purpose: Manage the Calibration process, Asset Management Database and Quality Program requirements in accordance with internal procedures, cGMP, ISO 13485 or any other applicable local or national standards.

General Responsibilities:

  • Manage the day-to-day activities to enable the facility and equipment to sustain a state of compliance related to calibration and other scheduled activities. These activities include the review, selection and approval of appropriate calibration standards, calibration methods and intervals
  • Asset Management Database Administrator responsibilities:
    • First point of contact for end user question s and issues
    • Conduct all departmental end user trainings related to the asset management database
    • Initiate and manger applicable quality processes towards continuous improvement of the database such as: changes to existing workflows/configuration, creation of new workflows not currently implemented, integration of database information to support quarterly metrics reporting and end user process efficiencies
  • Maintain compliance of the Facilities Department to ACC Quality Program requirements
    • Responsible for ensuring Facilities Department Quality Processes Workflows (Quality Events, Change Controls, Deviations, Audit Findings, etc.) are properly initiated, executed and approved
    • Ensure completeness and accuracy of Facilities documentation and files
    • Identify procedural gaps related to Asset Management
    • Identify KPI’s and support Facilities Manager with quarterly metrics reporting
  • Collaborate with Facilities Engineers as needed
  • Support the Facility Manager with project identification and implementation. This includes participating on various project teams and acting as an SME when required
  • Support Facilities Manager with budgeting process
  • Assess employee training needs, training plan development and employee development, ensuring training compliance for the department. Continuously assess job levels, roles and responsibilities for Facilities personnel
  • Maintain consistent communication with Facilities Manager on key facility issues, potential issues and how they may be resolved, including personnel actions such as: employment, termination, disciplinary, performance and salary review
  • Perform all other duties as assigned by Facilities Manager

Knowledge and Skill Requirements:

  • Knowledge of cGMP, ISO 13485, and quality management system requirements
  • Knowledge of calibration methods and familiarity with ISO 17025 standard
  • Detail oriented, high level of accuracy, attention to detail and excellent organizational skills
  • Familiarity with mechanical systems and equipment relating to electronics, controls and building automation
  • Ability to effectively communicate across departments as well as with contracted vendors

Education and Experience:

  • Bachelor's Degree in Engineering, Facility Management, or other relevant discipline. Degree not required with 10 years relevant industry experience working in Facilities, Validation or Calibration department
  • Must have 7 years experience in a supervisory or managerial role which includes: labor productivity management, vendor management and budgeting
  • Project manager experience is a plus

General Competencies:

  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Manages personnel resources efficiently and is continuously assessing personnel growth and training needs with a focus on team growth
  • Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient workspace, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; in compliance with quality system requirements
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently: talk, listen, sit, stand, walk, use hands or reach with hands/arms
Occasionally: climb ladder, balance, stoop, kneel, crouch, crawl, lift and/or carry 1-50lbs, work near moving mechanical parts, exposed to outdoor weather conditions and extreme cold (non-weather).
Moderate noise is typical for some work environments of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Associate Manager, Facilities here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Facilities Supervisor

In this role, you will supervise the day-to-day operations of the maintenance group which includes planned maintenance activities and unplanned repairs of the facility and its equipment.

General Responsibilities:

  • Provide excellent support to the various groups within the building
  • Support the facilities maintenance team by providing leadership and technical, resource and planning assistance
  • Maintain a working knowledge of the team’s workload to efficiently delegate unscheduled work requests
  • Confirm scheduled and unscheduled work is completed by their due dates
  • Complete reviews of all maintenance work in a timely manner
  • Prioritize work while considering the maintenance team’s activities as well as the needs of the groups we support
  • Provide open lines of communication with groups we support
  • Oversee onsite contractors
  • Must be available for on-call for emergencies

Education and Experience:

  • A Bachelor's Degree in a scientific or engineering field or an equivalent combination of experience and/or education is required
  • A minimum of five years’ experience troubleshooting, repairing, and maintaining typical building systems such as steam, electrical, plumbing, pneumatic and HVAC systems preferably in cGMP manufacturing facility or other highly regulated industry. Building automation experience is a plus
  • A minimum of three years’ experience in a leadership/supervisory role
  • Previous experience in cGMP or another highly regulated industries where exceptional organizational and documentation skills, accuracy and attention to detail are paramount to the success of the company
  • Proficient with computerized maintenance management systems. Blue Mountain RAM a plus

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Facilities Supervisor here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree in a scientific or engineering or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Technician

2nd shift, 2pm-10:30pm

To work as a member of the Production Team to manufacture products in compliance with ACC procedures.

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Basic computer skills needed

Education and Experience:

  • A minimum of a high school diploma and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

LAL Production Technician

With direct supervision this individual will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. Individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs.
  • Basic computer skills needed

Education and Experience:

  • A minimum of a high school diploma and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for LAL Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School diploma and 0-2 years related industry experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Lead Technician

Purpose: With minimal supervision this individual will deliver leadership and excellence in manufacturing ACC and SKK Products. The incumbent assists Management with scheduling to meet site demands and observes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Provide interactions with support groups/departments to ensure accurate communication and continuous flow of manufacturing processes. Provide support to integrate best practices, where appropriate, into manufacturing.

General Responsibilities:

  • Primary contact for troubleshooting and issue resolution or escalation
  • Create and follow up on work orders
  • Communicate/coordinate days scheduling and staffing plan
  • Re-allocate staff as needed during the day (breaks, lunch, training, etc.)
  • Oversight and execution of all routine and critical operations as well as commissioning and validation activities
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Ensure documentation is complete, reviewed, and meets good documentation practices
  • Update SOP's as required
  • Responsible for floor inventory and communicating deficiencies
  • Recommend/implement process changes/improvements or safety/ergonomic improvements
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks
  • Responsible for interviewing candidates
  • Provide timely feedback on staff’s performance
  • Address minor personnel issues timely
  • Escalate major personnel issues to the supervisor
  • Act as a resource/subject matter expert (SME) for staff
  • Conduct training and assess effectiveness
  • Assess staff skill sets and provide feedback to supervisor
  • Must be able to work overtime as required
  • Must be able to work weekends as required
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Computer skills are necessary in this function
  • Act as a role model (lead by example)

Education and Experience:

  • Associates degree and 1-4 years related experience or 4-6 years industry experience or an equivalent combination of experience and/or education required
  • Bachelors of Science degree or equivalent is an advantage with 2-4 years of GMP Manufacturing experience

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Lead Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates degree or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Research Scientist

Develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. Develop new products revolving around the current technology and new concepts leading to new technologies.

General Responsibilities:

  • Adapt and develop new technologies around the LAL system
  • Develop projects that will enhance the scientific understanding of the current products with the goal of improvement and the introduction of new products
  • Expand the range of products within the framework of ACC
  • Provide the technical expertise to conceptualize and implement new research areas
  • Provide technical support when necessary
  • Supervise Research and Development staff

Knowledge and Skill Requirements:

  • Protein Chemistry/Biochemistry including enzymology and purification
  • The use of spectroscopic, chromatographic and molecular biological techniques
  • Assay Development
  • Technology transfer and scale-up
  • Supervisory experience

Education and Experience:

  • A minimum of a PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience and/or education required.
  • Several years of experience in assay development, protein chemistry and protein purification. Additional expertise in Molecular Biology and supervisor/management experience is desired.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Senior Research Scientist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Sr. Software Engineer

Design and develop software to support the manufacture, sale and support of ACC’s endotoxin and glucan detection products and develop/maintain software to support company’s line of business.

General Responsibilities:

  • Analyze User Needs and develop high-quality, innovative software with operational efficiency.
  • Work closely with BAs, SMEs and Software Developers to develop software requirements specification and software design specifications
  • Design and implement software for Bio/medical devices and systems from requirements to production and commercial deployment
  • Responsible for design, debug, and integration of software C#/Java applications running in a MS Windows environment
  • Give aid and guidance to junior engineering staff.
  • Lead and direct activities on development  project
  • Contribute to the improvement of the development life cycle.
  • Be self-empowered, take ownership of, and responsibility for your work
  • Collaborate and communicate effectively with team members and with other teams
  • Work independently and know when to ask for help
  • Perform comprehensive unit and integration testing of all software produced
  • Participate in group design and code reviews
  • Review code and work with software quality assurance to ensure that all software meets company or medical device standards
  • Stay abreast of the latest technology and industry best practices
  • Understand the software development life cycle

Knowledge and Skill Requirements:

  • Must demonstrate significant proficiency in C#/Java
  • Documents and demonstrates solutions by developing documentation, flowcharts, layouts, diagrams, code comments and clear code. 
  • Ability to gather and understand User Needs/Requirements
  • Ability to work in a very fast paced environment
  • Familiarity with software configuration management tools, defect tracking tools, and peer review
  • Familiarity with relational databases
  • Any exposure or knowledge of the Bio/Medical industry is a strong plus

Nice To Have:

  • Experience implementing software for class I or II medical devices
  • Object-oriented design and development, and C#, are strongly preferred
  • Experience with Visual Studio, Git, Helix ALM and Microsoft Team Foundation Server
  • Experience with IEC-62304, ISO-13485, and ISO-14971

Education and Experience:

  • Bachelor’s Degree in Biomedical Engineering, Software Engineering, Computer Science, Applied Mathematics, Electrical Engineering or a related field or equivalent combination of education and experience.
  • 8 or more years of software development using C#/Java
  • Good written and oral communications skills, strong attention to detail and willingness to follow directions and established procedures with minimal supervision. 

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Sr. Software Engineer here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Technician

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Basic computer skills needed

Education and Experience:

  • A minimum of a high school diploma and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

CTS  Analyst

General Responsibilities:

  • Perform testing using each of the three LAL (limulus amebocyte lysate) methods-gel clot, turbidimetric & chromogenic
  • Interpret results, perform pipetting
  • Report writing, interact with clients relative to sample testing
  • Database entry
  • Utilize calibrated/certified equipment & instrumentation,
  • Maintain certification in all three LAL methods

Knowledge and Skill Requirements:

  • 1 years exp. in a lab environment
  • Strong organizational skills
  • Must be detail oriented with good aseptic/laboratory technique
  • Possess the ability to work independently as well as with others in a fast paced environment
  • Excellent oral & written communication skills
  • Possess a working knowledge of cGMP, ISO 9001, ISO 13485 & internal operating procedures
  • Required to pass a pipetting proficiency training and certification course.
  • Other – Hepatitis B vaccination

Education and Experience:

  • Bachelor’s Degree in Chemistry, Biochemistry, a related scientific discipline, or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for CTS Analyst here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Regulatory MGR / Associate Director / Director (Level Dependent Upon Experience)

Purpose: To assure regulatory compliance at Associates of Cape Cod, Inc.

Knowledge and Skill Requirements:

  • Knowledge of:
    • 21CFR, esp. Parts 210, 211, 600-610, 600's as appropriate, and 800 as appropriate
    • Canadian Medical Device Regulations, SOR/98-282
    • Directive 98/79/EC of the European Parliament and of the Council
    • FDA Guidance documents, esp. Guideline for Validation of Limulus Amebocyte Lysate Test; Changes to an Approved Application: Biological Products; Sterile Drug Products Produced by Aseptic Processing; Investigating Out-of-Specification (OOS) Test Results
    • Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004)
    • Guidance for Industry - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
    • Relevant ISO documents, esp. 13485; 14971
    • Relevant EU and JP regulations
    • Relevant USP chapters
  • Good communication and writing skills
  • Project management and risk management
  • Design control

Education:

  • At least a Master's degree and three years' experience in the regulatory field or an equivalent combination of experience and/or education required
  • RAC certification preferred
  • Experience on project teams (new product development) with submissions to regulatory bodies

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Regulatory MGR / Associate Director / Director here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Master's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Control Analyst I

Grow your career in life sciences on Cape Cod!

In this role you will perform chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with cGMP, ACC SOPs, and FDA Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

Knowledge and Skill Requirements:

  • Organizational skills
  • General laboratory skills
  • Must be detailed oriented and show proficiency in aseptic and laboratory technique
  • Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
  • Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
  • Required to pass a pipetting proficiency training and certification course.

Education and Experience:
A minimum B.S. degree in a relevant scientific discipline with 0-2+ years relevant laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Control Analyst I here.

In your cover letter please answer the following:

  • How many years of Quality Control experience do you have?
  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.