Quality Assurance Specialist III

As a Quality Assurance Specialist III, you will manage change controls, ensuring compliance with regulatory requirements, and oversee CMO-related activities. You will maintain programs and processes to produce high-quality products compliant with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). This role involves conducting investigations, participating in cross-functional meetings, and applying Root Cause Analysis tools.

Responsibilities

• Manage change controls and oversee CMO-related activities.
• Ensure compliance with applicable regulatory requirements.
• Maintain programs to ensure product quality and compliance with cGMPs and GLPs.
• Conduct and document major and minor deviation investigations.
• Review Executed Batch Records for Biologics DS and DP.
• Participate in cross-functional meetings with internal and external parties.
• Apply Root Cause Analysis tools to identify causes and propose actions.
• Support management of quality system records and adherence to targets.
• Maintain tracking tools and send periodic reminder notifications.
• Develop and generate quality system metrics for management review.
• Maintain and improve quality systems processes.
• Work with operating entities to follow-up on quality issues.
• Develop training programs regarding quality product production.
• Assist in compliance audits as required.
• Write and implement changes to controlled documents such as SOPs and Specifications.
• Provide guidance and technical knowledge for junior staff.

• Proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Strong application of QA principles, concepts, industry practices, and standards.
• Knowledge of FDA/EMEA standards and quality systems.
• Understanding of Six Sigma, LEAN, and root cause analysis tools.
• Strong investigation skills and report writing skills.
• Excellent verbal, technical writing, and interpersonal skills.
• Proficiency in Microsoft Office applications.

• 5+ years of relevant experience in a GMP environment with a BS or BA.
• 3+ years of relevant experience with an MS.
• Prior experience in the pharmaceutical industry is preferred.
• Experience in QA review of Executed Batch Records.
• Technical writing skills for deviations and investigations.

The position offers a hybrid work schedule with on-site work on Wednesdays and Thursdays and remote work on Mondays and Fridays. This role provides a long-term opportunity with benefits including 2 weeks of PTO and 9 paid holidays.

Job Type & Location

This is a Contract position based out of Parsippany-Troy Hills, NJ.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/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 Type

This is a hybrid position in Parsippany-Troy Hills,NJ.

Application Deadline

This position is anticipated to close on Dec 17, 2025.

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.