• Quality Assurance Specialist II

    Actalent (Parsippany Troy Hills, NJ)


    Job Title: Quality Assurance Specialist IIJob Description

     

    The Quality Assurance Specialist II is responsible for managing change controls and coordinating with cross-functional departments to ensure compliance with regulatory requirements. This role involves maintaining programs to ensure high-quality products and compliance with Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). The specialist will independently conduct, complete, and document deviation investigations related to GxP operations and perform reviews of Executed Batch Records for Biologics Drug Substance (DS) and Drug Product (DP).

    Responsibilities

    + Manage change controls and complexities for Contract Manufacturing Organizations (CMOs).

    + Perform activities to ensure compliance with regulatory requirements.

    + Maintain programs and processes for high-quality products and compliance with cGMPs and GLPs.

    + Conduct and document major and minor deviation investigations.

    + Review Executed Batch Records for Biologics DS and DP.

    + Participate in cross-functional meetings with internal and external parties.

    + Apply Root Cause Analysis tools to identify causes and propose corrective actions.

    + Support management and tracking of quality system records for adherence to targets.

    + Maintain tracking tools/databases and send periodic reminder notifications.

    + Support management review process with quality system metrics and issue escalation.

    + Assist in compliance audits and write/implement changes to controlled documents.

    + Provide guidance and technical knowledge for junior staff and participate in training program development.

    Essential Skills

    + Proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

    + Strong application of QA principles, concepts, industry practices, and standards.

    + Knowledge of FDA/EMEA standards and quality systems.

    + Experience with Six Sigma, LEAN, and root cause analysis tools.

    + Strong investigation and report writing skills.

    + Excellent verbal, technical writing, and interpersonal skills.

    + Proficiency in Microsoft Office applications.

    Additional Skills & Qualifications

    + 5+ years of relevant experience in a GMP environment with a BS or BA.

    + 3+ years of relevant experience with a MS degree.

    + Experience in the pharmaceutical industry, particularly with QA reviews of Executed Batch Records.

    + Familiarity with technical writing, deviations, and investigations.

    Work Environment

    This position offers a hybrid work model, with work-from-office on Wednesdays and Thursdays, and work-from-home on Mondays and Fridays. Enjoy a long-term opportunity with benefits including two weeks of paid time off and nine paid holidays.

     

    Job Type & Location

     

    This is a Contract position based out of Parsippany-Troy Hills, NJ.

    Pay and Benefits

    The pay range for this position is $40.00 - $45.00/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 Parsippany-Troy Hills,NJ.

     

    Application Deadline

     

    This position is anticipated to close on Dec 16, 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.