Job Information
Actalent QA Associate 2nd Shift SUN-THURS in Allendale, New Jersey
Job Title: QA Associate 2nd Shift SUN-THURS
Job Description
The QA Associate will uphold compliance with cGMP and cGTP regulations for pre-clinical, clinical, and commercial manufacturing processes. This role includes performing raw material inspections, issuing batch records, and ensuring adherence to FDA and Worldwide Quality & Compliance standards.
Responsibilities
Read, understand, and follow all cGMP and cGTP documentation for Quality System Functions.
Maintain compliance for pre-clinical, clinical, and commercial manufacturing processes.
Perform inspections and releases of raw materials in accordance with SOPs.
Issue and review batch records and maintain documentation such as logbooks and training binders.
Perform Accessioning of incoming apheresis and line clearance prior to manufacturing operations.
Build Quality into all aspects of work by maintaining compliance with quality requirements.
Attend all required Quality & Compliance training sessions.
Essential Skills
Quality assurance experience.
Understanding of batch record review and material flow.
Ability to work the 2nd shift from Sunday to Thursday, 2:30 PM to 11 PM.
Experience with document management and QC data review.
Additional Skills & Qualifications
BS degree in a scientifically related field.
Experience in a biologics or biotechnology company is preferred.
Technical understanding of aseptic manufacture of biologics is advantageous.
Knowledge of cGMP and cGTP regulations.
Background in the GMP industry.
Work Environment
The role requires working in a team-oriented environment with occasional weekend and holiday shifts. The position may involve exposure to infectious diseases, requiring the use of personal protective equipment (PPE) when handling specimens and chemicals. The work setting includes specialized equipment and moderate noise typical of a manufacturing facility. Training in GXP, SOP & WI, and gowning qualification is provided.
Job Type & Location
This is a Contract to Hire position based out of Allendale, NJ.
Pay and Benefits
The pay range for this position is $30.00 - $30.00/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 fully onsite position in Allendale,NJ.
Application Deadline
This position is anticipated to close on Mar 24, 2026.
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.