Quality Assurance Specialist

We are seeking a motivated and detail-oriented Quality Assurance Specialist to support day-to-day quality operations and ensure compliance across our manufacturing processes. This role provides hands-on QA support on the production floor, assists with document control activities, and works closely with Manufacturing, Warehouse, and Quality Control teams to maintain high standards of product quality and cGMP compliance. The ideal candidate is proactive, organized, and enjoys working in a fast-paced, mission-driven environment. This position offers an excellent opportunity to gain well-rounded experience across quality operations, documentation, and floor oversight—particularly within advanced therapeutic manufacturing.

Responsibilities

• Provide QA support for daily manufacturing operations in accordance with approved SOPs and cGxP requirements.
• Assist in reviewing executed batch records, logbooks, and production documentation for accuracy, completeness, and cGMP compliance.
• Support deviation initiation and investigation activities, including documentation, root cause analysis, and timely closure.
• Assist with material release.
• Perform routine QA walkthroughs on the manufacturing floor and escalate quality events per established procedures.
• Support document control activities, including the review and routing of SOPs.
• Participate in change control processes for operational and documentation changes.
• Support quality oversight of product status, including shipping documentation and release readiness.
• Identify and help correct non-compliance with cGMP and GDP requirements.
• Perform other QA-related duties as assigned to support operational needs.

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.).
• 1-5 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.).
• Basic understanding of cGMP principles and regulatory requirements (FDA, EMA, ICH).
• Familiarity with quality management systems and GDP practices in a GMP facility.
• Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment.
• Ability to work both independently and collaboratively with cross-functional teams.
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset.

• Experience in cell therapy or cell-based manufacturing is a plus.
• Familiarity with TrackWise Digital electronic QMS, LabVantage and SAP.

The work environment is based in Bridgewater, fostering a fast-paced and dynamic atmosphere. The position involves working closely with cross-functional teams and requires a commitment to maintaining high standards of compliance and quality. The role provides an opportunity to work within advanced therapeutic manufacturing, offering a unique and enriching experience.

Job Type & Location

This is a Contract position based out of Bridgewater, NJ.

The pay range for this position is $38.00 - $40.00/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 Bridgewater,NJ.

This position is anticipated to close on Apr 10, 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.