Careers

Last Updated 03 October, 2019

Project Manager

Posted: 03 October, 2019

General Responsibilities:
The Project Manager will lead members of cross-functional project teams to create and implement detailed project plans while ensuring stakeholder support. This will include defining key project constraints such as scope, schedule, resources and risks, and monitoring project performance relative to the project schedule commitments.  In addition, the project manager will suggest and implement corrective actions in order to meet defined project time lines and efficiently adapt project strategies to shifting priorities, as well as potential and realized changes to project constraints. Communication of project performance to the team and organization in an effective manner that facilitates informed decision-making will also be required. The Project Manager will coordinate task execution, kick-off meetings, project team meetings, management project reviews and post-mortem / project review meetings. Identification of process improvement opportunities, and development of recommendations to capitalize on these opportunities, will be required.

Knowledge and Skill Requirements:

  • Demonstrated history of strong leadership and negotiation skills, as well as the ability to effectively assimilate and communicate complex information from multiple sources and proven ability of successful cross-functional team collaboration is required.
  • Ability to recognize and lead the resolution of project issues and roadblocks is an essential requirement for this position.
  • Ability to lead and motivate the team.
  • Excellent verbal, written and presentation skills are required.
  • Experience in the medical device industry is preferred, but not required.
  • 21 CFR Part 11 experience preferred, but not required.
  • Proficiency using Smartsheet is preferred.
  • Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint and Outlook) is required.
  • This position will be based in Falmouth, MA.

Education and Experience:

  • PMP certification is highly desired, but not required.
  • A minimum of 3 to 5 years of experience within project management.
  • A minimum of a Bachelor’s degree in Business, Project Management, or equivalent combination of education and work experience is required.
  • Master’s degree in Business or related fields is preferred.

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Project Manager 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?

Sr. Training Specialist

Posted: 03 October, 2019

General Responsibilities:

  • Administer the electronic Learning Management System (LMS)
  • Lead the planning of all training activities for new hires and existing employees including permanent and temporary employees and conduct all applicable new hire training in collaboration with responsible departments
  • Collaborate with Functional Area Management in the enhancement of the annual Bleed Technician training program
  • Provide training and support to employees on use and scope of the Learning Management System
  • Develop, expand and manage a company-wide training  and competency program for internal and external functions with input from subject matter experts
  • Provide support to departments responsible for customer and distributor training activities
  • Lead safety, human resources and other functional specific training programs and training record evidence via systems external to LMS; lead the incorporation of external training into the LMS system, eliminating paper records
  • Responsible for oversight and coordinating the use of ACC’s Training Grant; work with subject matter experts to determine the appropriate training to be included under the grant
  • Conduct ongoing reassessment of training requirements for all departments and individuals in collaboration with department managers and modify LMS training matrix, programs and modules as required
  • Develop and manage a plan for training competency with the use of quizzes for appropriate procedures, and other competency methods
  • Collaborate with department heads for current hands on competency training, and incorporate such competency training records within LMS
  • Monitor all individuals training performance and provide reports to management routinely and as requested
  • Generate training materials and training aids across all functional areas, in collaboration with subject matter experts
  • Design and provide training reports for use by employees and managers from LMS system as requested and/or scheduled
  • Coordinate and conduct mandatory annual and periodic training per training plans
  • Prepare for and participate in customer, regulatory and internal audits and
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Experience in an ISO/FDA regulated industry
  • Experience working with electronic Learning Management Systems preferred
  • Experience performing training activities
  • Knowledge of FDA GMPs, ISO 13485 and applicable regulations
  • Experience in developing training systems/programs across disciplines

Education and Experience:
A minimum of a Bachelors degree or an equivalent combination of experience and education required. Five or more years corporate training experience with strong knowledge of Learning Management Systems, instructional/curriculum design, competency based training and platform/presentation skills.

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Sr. Training Specialist 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?

Controller

Posted: 19 September, 2019

General Responsibilities:

  • Strong analytical skills and business judgment to provide general financial support to the business.
  • 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 implementing 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:

  • SOX experience
  • Manufacturing experience
  • Product line P&L
  • Economic Value Added Calculations
  • Multiple Currency experience.
  • Biopharma industry experience a plus
  • Knowledgeable in the use of Microsoft Dynamics Great Plains
  • Cost Accounting experience preferred.
  • Supports Y/E physical inventories and reconciliation
  • Balance sheet reconciliation and control

Education:

  • A minimum of a Bachelor’s Degree in Accounting/Finance, Business or equivalent, CPA preferred
  • A minimum of 3 - 5years experience required.
  • Skills in planning, finance, analysis, innovation and communication.

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 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?

Research Associate

Posted: 19 September, 2019

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)

Posted: 19 September, 2019

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?

Process Engineer

Posted: 7 November, 2018

Purpose: This position will provide primary product technical support to the production of SKK and ACC products. In addition, there will be a significant role providing support for new product development projects and quality system events for existing products.

Knowledge and Skill Requirements:

  • Excellent technical written and oral communication skills, demonstrated critical thinking and problem solving skills
  • Demonstrated experience in leading teams, contributing technical support in a team setting, and strong troubleshooting skills. Attention to detail and excellent organizational skills is essential
  • Ability to work both independently and in a cross-functional team environment
  • In-depth knowledge of FDA cGMP and ISO 13485 regulatory requirements required
  • Demonstrated experience in creating validation or technical study protocols
  • Experience with an electronic document management system required
  • Design control and project management skills desired
  • Ability to work with Japanese colleagues

Education:

  • Ideal candidate will have a minimum of a Bachelor's Degree in a Science or Engineering discipline or an equivalent combination of experience and/or education required
  • At least 8 years of experience in the medical device, pharmaceutical, or biotech manufacturing industry
  • Knowledge of pharmaceutical/biopharmaceutical production processes required, familiarity with ACC processes and testing preferred
  • Experience in running assays with ACC reagents and instruments preferred

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Process Engineer 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?

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

Posted: 31 August, 2018

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

Posted: 23 May, 2018

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)

Posted: 14 May, 2018

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.