Qa/qc Specialist

Job Title: QA Associate - 1st Shift Tuesday to Saturday

Job Description

The QA Associate is responsible for ensuring compliance with all cGMP and cGTP documentation related to Quality System Functions. This role involves maintaining compliance for pre-clinical, clinical, and commercial manufacturing. Responsibilities include performing raw material inspections and releases, managing batch records, and maintaining quality documentation.

Responsibilities

• Read, understand, and follow all cGMP and cGTP documentation for Quality System Functions including SOPs and WIs.
• Maintain compliance for pre-clinical, clinical, and commercial manufacturing.
• Perform raw material inspections and raw material releases according to SOPs and in compliance with regulatory standards.
• Issue and maintain all cGMP and cGTP documentation, including logbooks and training binders.
• Perform accessioning of incoming apheresis.
• Conduct line clearance prior to manufacturing operations.
• Ensure compliance with FDA and Worldwide Quality & Compliance regulations.
• Attend all required Quality & Compliance training sessions at specified intervals.

Essential Skills

• Quality assurance experience.
• Experience with batch record review.
• Working knowledge of cGMP and cGTP regulations.
• BS degree in a scientifically related field.

Additional Skills & Qualifications

• Some experience in a biologics or biotechnology company is preferred.
• Technical understanding of the aseptic manufacture of biologics is preferred.
• Must come from a GMP industry.

Work Environment

The QA Associate will work in a team-oriented environment and may need to work on weekends, holidays, and as required by the company. The role involves exposure to infectious diseases transmittable through human blood, tissues, or bodily fluids. Proper personal protective equipment (PPE) is necessary when handling human specimens, gases, corrosive chemicals, and liquid nitrogen. The work involves handling specialized equipment and the moderate noise levels of a manufacturing facility. Required training includes GXP, SOP & WI, Safety, and Gowning qualification.

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 Jun 1, 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $30