What are the responsibilities and job description for the QA Associate 1st Shift TUES-SAT position at Actalent?
We are seeking a dedicated QA Associate for the 1st Shift (Tuesday to Saturday) to ensure the highest standards of quality and compliance within our manufacturing operations. The role involves reading, understanding, and following cGMP and cGTP documentation for Quality System Functions, ensuring compliance in all aspects of pre-clinical, clinical, and commercial manufacturing.
Responsibilities- Maintain cGMP and cGTP compliance for all manufacturing processes.
- Perform raw material inspections and release according to SOPs and regulatory standards.
- Issue and maintain all cGMP and cGTP documentation, including logbooks and training binders.
- Perform accessioning of incoming apheresis and line clearance prior to manufacturing operations.
- Build quality into all work aspects by adhering to all quality requirements.
- Ensure compliance with all FDA and Worldwide Quality & Compliance regulations.
- Attend all required Quality & Compliance training sessions.
- Support Quality Systems and client procedures, including document management and QC data review.
- Strong quality assurance skills.
- Experience with batch record review and material flow.
- Ability to perform under direct supervision.
- Knowledge of cGMP and cGTP regulations.
- BS degree in a scientifically related field.
- Experience in a biologics or biotechnology company is preferred.
- Technical understanding of aseptic manufacture of biologics is preferred.
- Experience in the GMP industry is required.
The role requires working in a team-oriented environment and interacting with clients. The position demands availability during weekends, holidays, and other times as required by the company. The work environment may expose you to infectious diseases and requires proper use of personal protective equipment (PPE). You will be working with specialized equipment and handling the standard/moderate noise levels of a manufacturing facility. Training in GXP, SOP & WI, Safety, and Gowning qualification is provided.
Job Type & LocationThis is a Contract to Hire position based out of Allendale, NJ.
Pay and BenefitsThe 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 TypeThis is a fully onsite position in Allendale,NJ.
Application DeadlineThis position is anticipated to close on Mar 23, 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 for other accommodation options.
Salary : $30