Quality Control Specialist

Job Description

Job Description

Job Title: Quality Control Specialist

Job Description

We are seeking a dedicated Quality Control Specialist to join our dynamic team in the cell and gene therapy sector. This role offers the opportunity to work at a brand new site, supporting our cutting-edge CDMO operations. The successful candidate will be trained in a variety of analytical methods and will be responsible for maintaining high-quality standards in a fast-paced environment.

Responsibilities

• Perform and be trained in ELISA-based assays, Endotoxin testing, Flow Cytometry, and PCR analytical methods.
• Support operations at both the Newark and Princeton locations.
• Conduct quality inspections and manage materials, reagents, and live cells.
• Interact effectively with clients and health authorities, ensuring clear communication and maintaining professional relationships.

Essential Skills

• Master's Degree with 1+ years of experience in the pharmaceutical industry or GMP environment, focusing on analytical methods or Quality Control, OR a Bachelor's Degree with 2+ years of relevant experience.
• In-depth knowledge and hands-on experience with analytical assays, including Flow Cytometry, PCR, and ELISAs.
• Extensive Quality Control experience with a comprehensive understanding of compendial methods and regulatory guidance.
• Ability and willingness to learn and perform microbiological assays as part of the evolving needs of the team.
• Capability to thrive in a dynamic environment, manage multiple priorities, and adapt to evolving demands.
• Willingness to travel between facilities and work flexible hours, including evenings, weekends, and shift-based schedules as operational needs dictate.

Additional Skills & Qualifications

• Experience with LIMS, Endotoxin, Sterility, mycoplasma, and method qualification/validation, including supporting method transfer activities.
• Familiarity with FDA, EMEA, ICH, USP, GMP guidelines, and cGMP regulations related to QC labs and cell-based product manufacturing.
• Proven ability to support lab investigations, deviations, CAPAs, and change controls.
• Knowledge of Gene/Cell therapy products, particularly in clinical production.

Work Environment

This role is based in a growing CDMO specializing in Cell/Gene Therapy at a brand new site. The work environment is dynamic, offering opportunities to work with the latest technologies in a supportive team-oriented setting. Flexible hours, including evenings and weekends, may be required to meet operational demands.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $25.00 - $35.00/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 fully onsite position in Princeton,NJ.

Application Deadline

This position is anticipated to close on Nov 6, 2025.

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 [email protected] for other accommodation options.