Careers

Controller

General Responsibilities:

  • Strong analytical skills and business judgment to provide general financial support to the business.
  • Support Inventory, Cycle Count Internal Controls process design
  • Manage A/R and A/P processing, controls and credit risk
  • Prepares journal entries, reports and adhoc requests
  • Domestic balance sheet responsibility and reconciliation.
  • Conducts analyses, provides consulting, and makes recommendations to management on priorities, resources and schedules for complex programs
  • Has approval authority, as delegated.
  • Actively support budget preparation, forecasts and analysis to evaluate and predict business performance.
  • Responsible for implementation of  and adherence to corporate internal control standards
  • May have project management responsibilities
  • Position objective is 70% of time spent on analysis & process re-design and 30% of time spent on closing books.

Knowledge and Skill Requirements:

  • Internal Control design/improvement
  • Inventory/Manufacturing/Cost Accounting
  • Product line P&L
  • Economic Value Added Calculations
  • Multiple Currency experience
  • Biopharma industry experience a plus
  • Microsoft Dynamics Great Plains a pus
  • Supports Y/E physical inventories and reconciliation
  • Balance sheet reconciliation and control

Education and Experience:

  • A minimum of a Bachelor's Degree in Accounting/Finance, Business or equivalent, CPA preferred
  • A minimum of 5 years managerial experience required
  • Skills in planning, finance, analysis, innovation and communication.

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.
  • Communicates well (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, good attendance record.
  • 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, maintains efficient work space, manages time well.
  • Manages workload, works efficiently, and meets goals and objectives.
  • 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

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Controller in your subject line.

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?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Product Development Associate

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company clinical product development pipeline while using various laboratory equipment for routine analyses (e.g., spectrophotometers, manual pipettes and automated liquid handlers etc)

  • Participate in the development, improvement and validation of new assays
  • Design, write and carryout experimental protocols.
  • Test analytical and clinical samples
  • Analyze laboratory results and prepare study reports.
  • Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products.
  • Follow Design Control requirements and SOPs in a GMP environment.
  • Maintain records in accordance with Quality Assurance Guidelines.
  • Participate in cross-functional activities.

Education and Experience:

The position requires a minimum of BS/MSc in Biochemistry, Chemistry or Biology with 5 years of relevant industry experience or equivalent combination of education and/or experience. 

General Competencies:

  • Scientific creativity, critical thinking, ability to innovate, and analytical problem solving.
  • Ability to accurately follow, draft and review technical documents, including test plans, protocols and reports.
  • Ability to work independently, as well as, with others in a fast paced laboratory environment.
  • Willing and able to drive projects to completion and to meet deadlines
  • Excellent written and oral communication skills.
  • Proficiency in software applications such as Word, Excel, PowerPoint.
  • Excellent use of manual, multichannel, and repeater pipettes. Able to accurately dispense small volumes consistently.
  • Hands-on experience with the use of automated liquid handling system is a plus
  • Other – Hepatitis B vaccination to be able to test clinical samples.

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Product Development Associate in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Facilities Administrative Assistant

General Responsibilities:

  • Review and enter routine facilities/calibration records
    • Work within the asset tracking database for entry of record information
  • Review and file work orders, daily activity logs, calibration files and preventive maintenance records
  • Coordinate vendors based on calibration and maintenance group’s instructions
  • Facilities Department meeting management (agenda’s, minutes, action items, etc.)
  • Convert technician job notes into SOP’s
  • Manage minor document changes within Qumas
  • Mange minor QE’s and deviations within Qumas
  • Submit/route purchase reqs
  • Acquire RMAs from vendors (Calibration, maintenance or repair)
  • Support Facilities and Calibration Supervisor and process with other admin duties as necessary

Knowledge and Skill Requirements:

  • Computer skills (MS Word, MS Excel, Adobe Acrobat, Calman/RAM)
  • Ability to maintain equipment files in neat and orderly manner
  • Ability to manage multiple tasks in a timely manner, work independently, meet deadlines
  • Flexibility and the ability to juggle priorities
  • Excellent communication, organizational and interpersonal skills
  • Must be able to take initiative with activities
  • Highly organized self-starter with ability to work well with others
  • Ability to learn new functions and operation systems within the Facilities and Calibration processes

Education and Experience:

  • One to three years of administrative experience preferred
  • Prior experience with proven ability to demonstrate interpersonal, written, verbal and organizational skills
  • A minimum of an associate degree or an equivalent combination of experience and/or education required.

General Competencies:

  • 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.
  • Works well with all ACC personnel and promotes a positive image of the Facilities department, and strives to solve issues raised by customers of the Facilities department.
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
  • Information organized and accessible, maintains focus, punctual, good attendance record

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Facilities Administrative Assistant in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate Degree?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Research Associate

General Responsibilities:

  • To perform analytical methods, including PAGE and protein determinations and general laboratory work
  • To manufacture specific materials for the recombinant chromogenic reagent project
  • To prepare LAL formulations as needed and perform LAL tests/assays as part of Research projects
  • To perform other assays and procedures such as enzyme activity assays
  • To become proficient with new techniques as required
  • Write SOPs and reports and prepare other paperwork as necessary, especially as related to the Quality System
  • To obtain project management experience
  • Use of various laboratory equipment for routine analyses
  • Operation of laboratory equipment using appropriate software
  • Designing and carrying out experimental protocols.
  • Following SOPs in a GMP environment.
  • Maintain records in accordance with Quality Assurance Guidelines.
  • Preparation of Research Reports.
  • Ability to interpret results from lab tests.
  • Conduct performance and analysis evaluations of competitive products.
  • Maintain supplies inventory and order items when needed.
  • Proper operation, standardization & maintenance of lab equipment.

Knowledge and Skill Requirements:

  • Good base knowledge of chemistry, biochemistry and biology
  • Thorough training and significant experience in standard concepts, practices and procedures within the LAL field as well as general laboratory techniques
  • Ability to work with minimal supervision
  • Ability to effectively communicate with peers and management as necessary and function well as a team member

Education:

  • A BSc, BA, MSc or MA degree in chemistry, biology or biochemistry is required
  • 5 years experience in an appropriate GMP laboratory setting working as a team member
  • Good communication skills both written and oral

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Research Associate in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: BSc, BA, MSc or MA or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Technical Services BET Specialist (2 openings)

General Responsibilities:

  • Provide technical support for endotoxin and glucan detection products.  This includes answering questions, troubleshooting for current ACC customers.
  • Knowledge of relevant instrumentation and softwares used for endotoxin and glucan detection by the end users
  • Troubleshoot/triage issues, problems and complaints in a timely manner, documenting them in CRM and providing trending to manager. Frequent follow up on all issues ensuring timely resolution of the customer’s issue.
  • As an outcome of triaging issues, determine if the issue is a complaint, write up an executive summary of the complaint, properly document in CRM and forward for documenting in QUMAS. Ensure continuity of follow ups and timely resolution of complaints.
  • Ability to effectively communicate and explain detailed and/or complicated technical issues in terms that benefit users and help resolve problems and issues.
  • Identify key technical issues to be addressed in client communications
  • Transmit information to customers in a clear and concise manner
  • Proper documentation of client interactions
  • Maintains Customer Database - monitor progress of potential customers’ product trials; follow up with customers regularly
  • Visit customers when necessary to troubleshoot problems
  • Participate in onsite or offsite workshops as needed
  • May be asked to deliver trainings/ presentations  during workshops
  • Documented proficiency with instrument calibrations and software validations.
  • Serve as a backup to perform instrument calibrations and validations.
  • Verifying in-service pipettes (as found) prior to their calibration.
  • Participate in laboratory testing, software evaluations and projects as needed.
  • Ability to travel (25% or more)
  • Be familiar with the quality policy for ACC
  • Be familiar and follow the ACC safety policy
  • Be familiar with and follow the standard operating procedures (SOP) for ACC
  • Obtain further training in areas identified by Supervisor or Manager, Technical Services

Knowledge and Skill Requirements:

  • Excellent communication skills
  • Demonstrated ability to speak in public forums
  • Work well in team-based assignments
  • Work well under pressure in a dynamic environment
  • Knowledge of photometric instrumentation and photometric instrumentation-related softwares and instrumentation
  • Knowledge of Microsoft SQL database
  • Must have good laboratory skills, including pipetting and aseptic technique
  • Knowledge of BET regulations and guidances
  • Knowledge and ability to perform work in compliance with applicable cGMP and ISO regulatory requirements
  • Required to pass a pipetting proficiency training and certification course.

Education:

  • A minimum of a Bachelor of Science degree or an equivalent combination of experience and/or educational requirement.
  • Concentration in biochemistry, chemistry, or microbiology.
  • Experience with customer database, presentation software, BET testing instrumentation and software, Quality System controlled work environments, GMP/ISO regulated work.

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Technical Services BET Specialist in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with BET Product Specialist in your subject line.

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?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with QC Analyst I in your subject line.

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?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Production Technician I (Saturday - Wednesday)

Purpose:
In this position you will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. You will carry out cGMP manufacturing operations based on Standard Operating Procedures. You would need to come onboard initially Monday thru Friday for a few months to train in gowning, filling, crimping, lyo, oven operation, and autoclave operation

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
  • 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
  • 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

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
  • Will train right person

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Manages workload, works efficiently, 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

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Production Technician Sat - Wed in your subject line.

In your cover letter please answer the following:

  • How many years of Manufacturing experience do you have?
  • Have you completed the following level of education: High school or equivalent?
  • Are you authorized to work in the United States?

Associates of Cape Cod, Inc. is an Equal Opportunity Employer.