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Quality Assurance Specialist

1 month ago

Clifton, New Jersey, United States Actalent Full time
Job Description

Job Title: Quality Assurance Specialist

Job Summary: We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with cGMP and cGTP regulations, performing raw material inspections, and maintaining accurate documentation.

Key Responsibilities:

  • Read, understand, and follow all cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.).
  • Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical, and commercial manufacturing.
  • Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.
  • Issue batch records and review media (intermediate) batch records.
  • Issue and maintain all cGMP and cGTP documentation, including but not limited to logbooks and training binders.
  • Perform accessioning of incoming apheresis.
  • Perform line clearance prior to manufacturing operations.
  • Build quality into all aspects of your work by maintaining compliance with all quality requirements.
  • Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).
  • Attend all required Quality & Compliance training at the specified intervals.

Requirements:

  • Read and understand cGMP and cGTP documentation.
  • Perform raw material inspections.
  • Issue and review batch records.
  • Maintain cGMP and cGTP documentation.
  • Accession incoming apheresis.
  • Perform line clearance.
  • Ensure FDA and Worldwide Quality & Compliance regulation adherence.

Work Environment:

  • Ability to work in a team-oriented environment and with clients.
  • Must be able to work during weekends, holidays, and as required by the company.
  • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
  • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
  • Ability to work with specialized equipment.
  • Ability to handle the standard/moderate noise of the manufacturing facility.

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.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.

DE&I are embedded into our culture through:

  • Hiring diverse talent.
  • Maintaining an inclusive environment through persistent self-reflection.
  • Building a culture of care, engagement, and recognition with clear outcomes.
  • Ensuring growth opportunities for our people.

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 process due to a disability, please email for other accommodation options.