• Quality Specialist

    Actalent (Princeton, NJ)


    Job Title: Quality SpecialistJob Description

     

    The Quality Specialist will perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. This role involves providing on-floor Quality Operations support for manufacturing, warehouse, and other technical operations.

    Responsibilities

    + Provide on-floor Quality Operations support for manufacturing, warehouse, and other technical operations, ensuring adherence to cGMP expectations.

    + Ensure all manufacturing activities comply with GMP and regulatory requirements.

    + Review and approve GMP documentation for accuracy and compliance.

    + Execute product-related activities, including apheresis material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment.

    + Ensure timely resolution and escalation of quality issues to support lot closure and product release.

    + Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies using structured root cause analysis tools.

    + Review and approve deviations and CAPAs, ensuring robust, timely, and compliant resolution.

    + Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.

    + Represent the Quality Operations department in team discussions and project meetings.

    + Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.

    + Participate in and support internal audits, facility walkthroughs, and regulatory inspections.

    + Proactively notify management of risks and help implement process improvements based on investigation outcomes.

    Essential Skills

    + 3+ years of cell therapy experience.

    + 3-5 years of GMP manufacturing experience.

    + Quality Assurance oversight for manufacturing floor.

    + ISO 7 gowning experience.

    + Technical/growth mindset.

    + Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry.

    + 5–7 years of QA experience in a GMP-regulated environment.

    + Strong knowledge of batch record review, aseptic operations, and environmental monitoring.

    + Demonstrated ability to lead and close complex quality investigations.

    Additional Skills & Qualifications

    + CDMO experience strongly preferred.

    + Proficient in investigation tools such as Fishbone diagrams, 5 Whys, and FMEA.

    + Excellent problem-solving skills with a focus on risk-based decision-making.

    + Ability to manage multiple priorities and thrive in a dynamic environment.

    + Flexibility to travel between facilities and work varying hours.

    Work Environment

    The role is based in a growing CDMO specializing in Cell/Gene Therapy. The site is brand new, offering a dynamic and innovative environment. The work involves being present on the manufacturing floor in ISO 7 environments, with flexibility required for varying hours, including evenings, weekends, and shifts as needed.

    Pay and Benefits

    The pay range for this position is $75000.00 - $85000.00/yr.

     

    401 medical dental vision

     

    Workplace Type

     

    This is a fully onsite position in Princeton,NJ.

     

    Application Deadline

     

    This position is anticipated to close on Jun 3, 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.