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Kelly Services Quality Compliance Specialist III in Cambridge, Massachusetts

Kelly is hiring a Quality Compliance Specialist III for one of our pharmaceutical clients in Cambridge, MA

  • 12 month contract to start

  • Pay:$43/hr

  • Remote to start but eventually be onsite

  • 3 years min experience

Highlights:

1). Should have Pharma Sciences industry experience

2). Clinical Supply, Regulatory Affairs, Technical support, external QPs

3). Quality systems exp

4). Batch documentation & disposition

5). Deviations, investigations, CAPA and change controls

OBJECTIVES:

• Manage projects and initiatives within the Pharmaceutical Sciences Quality organization to ensure Quality Compliance with GxP regulations and quality/technical agreements.

• Develop and manage relationships with other Pharmaceutical Sciences departments, Alliance Partners and Takeda Affiliates to ensure compliance with corporate and regulatory requirements for all business matters.

• This role is accountable for batch disposition for Clinical Trial Materials manufactured at CMOs on behalf of Takeda.

• The scope includes Drug Substance, Drug product and Finished Drug Product

• The employee will work with our external CMO partners and internal Quality teams within this department .In addition this functions works closely with Clinical Supply, Regulatory Affairs, Technical support, external QPs and any stakeholders involved in external supply

ACCOUNTABILITIES:

Performs or supports the execution of the following activities:

• Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.

• Responsible for reviewing batch documentation, data, certificates of analyses, technical reports

• Evaluating, designing and implementing quality systems relating to batch disposition

• Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required

• Supporting batch disposition processes as required

• Maintain Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals and generation of the Approved Supplier List.

• Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of R&D Quality & Clinical Operations departments.

• Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.

• Engage in cross-functional teams as a Compliance subject matter expert.

• Serve as a liaison between Global Regulatory Affairs, Commercial Clinical Submissions Management, Takeda LOCs and CMOs to support new drug applications and provide inspection supervision support for product approval in ex-U.S. countries.

• Identify and escalate regulatory issues and trends pertinent to Takeda products and O&B business to management, as appropriate.

• Provide pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).

• Receive overall project direction from management but completes most work independently.

• Complete required training and keep training files current.

• Additional tasks and duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor of Science (BS) degree and 3+ years’ experience in QA compliance and/or QA Product Disposition area in the pharmaceutical/biotech industry.

• Knowledge of cGMP regulations for US, EU and other markets.

• Effective time management, detail-oriented work style, and superior at teamwork and collaboration.

• Excellent organizational, presentation development and delivery skills.

• Proficient computer, verbal and written communication skills.

• Strong problem solving and data analysis skills.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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