QA Associate 2nd Shift TUES-SAT

The QA Associate will play a crucial role in maintaining compliance with cGMP and cGTP standards across pre-clinical, clinical, and commercial manufacturing processes. This position involves performing raw material inspections, issuing batch records, and managing various cGMP and cGTP documentation. The role requires a strong commitment to quality and compliance with FDA and worldwide regulations.

• Read, understand, and follow all cGMP and cGTP documentation for Quality System functions, including SOPs and Work Instructions.
• Maintain compliance with cGMP and cGTP standards for all manufacturing processes.
• Perform inspections and release of raw materials according to SOPs and regulatory standards.
• Issue batch records and review intermediate media batch records.
• Manage cGMP and cGTP documentation such as logbooks and training binders.
• Perform accessioning of incoming apheresis.
• Conduct line clearance prior to the start of manufacturing operations.
• Ensure compliance with FDA and worldwide quality and compliance regulations.
• Attend required quality and compliance training sessions.

• Quality assurance expertise
• Batch record review
• Knowledge of cGMP and cGTP regulations
• Experience with quality system functions and document management

• BS degree in a scientifically related field
• Experience in a biologics or biotechnology company preferred
• Technical understanding of aseptic manufacture of biologics is preferred
• Experience in the GMP industry

The QA Associate will work in a team-oriented environment, requiring weekend and holiday availability as per company needs. The role involves potential exposure to infectious diseases and requires the use of personal protective equipment (PPE) when handling human specimens and chemicals. The candidate must be able to work with specialized equipment and handle moderate noise levels typical of a manufacturing facility. Training in GXP, SOPs, Work Instructions, safety, and gowning qualifications is required.

This is a Contract to Hire position based out of Allendale, NJ.

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)

This is a fully onsite position in Allendale,NJ.

This 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