QA Associate I 2nd Shift

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.

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

The pay range for this position is $30.00 - $31.00/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 Apr 12, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $30 - $31