QA Level II

Job Title: Quality Batch Record ReviewJob DescriptionRead, 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 and maintain all cGMP and cGTP documentation, including but not limited to logbooks and training binders. Perform Accessioning of incoming apheresis. Conduct line clearance prior to manufacturing operations. Build Quality into all aspects of your work by maintaining compliance to 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+ Quality Assurance+ cGMP and cGTP documentation+ Raw material inspections+ Issuance of batch records+ Accessioning of incoming apheresis+ Line clearance+ Compliance with FDA and Worldwide Quality & Compliance regulations+ Document management+ Review of QC data+ Material releases+ Final product releasesSoft Skills+ Team-oriented+ Attention to detail+ Compliance-focused+ Ability to work with clientsJob TypeThis is a Contract-to-Hire position with a duration of 6 Month(s).Work SiteThis is a fully on-site position in Allendale, New Jersey.Work EnvironmentMust have the ability to work in a team-oriented environment and with clients. Must be able to work during the weekend, 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. Must have the ability to work with specialized equipment. Must be able to handle the standard/moderate noise of the manufacturing facility. GXP training, SOP & WI training, Safety Training, and Gowning qualification are required.About ActalentActalent 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 & InclusionAt 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 peopleThe 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.