Job Title: Quality Assurance SpecialistJob Description 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.Hard Skills
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
Soft Skills
Team-oriented
Attention to detail
Strong compliance adherence
Job TypeThis is a contract position with a duration of 4 Month(s).Work SiteThis is a fully on-site position in Allendale, New Jersey.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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
