• QA Compliance Specialist III

    Actalent (Waltham, MA)


    Job Description: Sr. Product Quality Assurance (PQA) Analyst

     

    The Sr PQA Analyst supports day-to-day Quality Assurance activities related to Third Party Manufacturing (TPM)/CMO plants. Responsibilities include approving manufacturing directions, reviewing investigations, assessing product impact, and managing corrective and preventive actions. This role also evaluates supplier change notifications, monitors process trends, performs annual Product Quality Reviews, and serves as a liaison between regulatory areas and TPM plants.

    Responsibilities:

    + Maintain effective relationships with internal departments and TPM sites.

    + Ensure production at TPM sites complies with current Good Manufacturing Practices (cGMP), local procedures, and provided specifications.

    + Review and approve manufacturing directions and ensure TPM procedures meet regulatory and quality standards.

    + Support global quality projects including planning, risk analysis, and implementation.

    + Oversee investigations related to process, laboratory, and raw materials, ensuring thorough documentation and product impact analysis.

    + Conduct annual Product Quality Reviews in compliance with global procedures.

    + Participate in Trend Review Board and Global Change Review Board (GCRB) meetings.

    + Generate and manage change plans related to TPM plant changes.

    Qualifications:

    + Bachelor’s degree in Engineering or Science.

    + 6+ years of experience in pharmaceutical operations, preferably in biologics.

    + Strong knowledge of GMP regulations and quality standards.

    + Experience with Change Plans, Exception Reports, SAP, and LRMS preferred.

    + Excellent analytical, communication, and interpersonal skills.

    + Ability to work across multicultural teams and communicate at all organizational levels.

     

    If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com

    Pay and Benefits

    The pay range for this position is $45.00 - $52.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a hybrid position in Waltham,MA.

     

    Application Deadline

     

    This position is anticipated to close on Oct 10, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.