Quality Control Specialist

Job Description

Job Description

Job Title: Quality Control Specialist
Job Description

Join a dynamic team as a Quality Control Specialist where you will be instrumental in ensuring the highest standards in pharmaceutical and GMP environments. This role provides an exciting opportunity to work with cutting-edge technologies in cell and gene therapy at a brand-new facility.

Responsibilities

• Perform Elisa based assays, Endotoxin, Flow Cytometry, and PCR analytical methods.
• Receive training on various analytical methods and demonstrate a willingness to learn.
• Support operations across two locations, with primary duties in both Newark and Princeton.
• Conduct microbiological assays as part of the evolving team needs.
• Travel between facilities and work flexible hours, including evenings and weekends, as required.
• Interact with clients and health authorities effectively, maintaining strong verbal and written communication.

• 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 to thrive in a dynamic environment, managing multiple priorities.

• Experience with LIMS, Endotoxin, Sterility, mycoplasma, and method qualification/validation.
• Familiarity with FDA, EMEA, ICH, USP, GMP guidelines, and cGMP regulations.
• Proven ability to support lab investigations, deviations, CAPAs, and change controls.
• Knowledge of Gene/Cell therapy products, particularly in clinical production.

Work in a growing CDMO focused on cell and gene therapy in a brand new, state-of-the-art facility. The environment is dynamic and requires adaptability to various shifts and operational needs. The role involves frequent travel between locations and offers the opportunity to engage with advanced technologies in a collaborative team-oriented setting.

Job Type & Location

This is a Contract to Hire position based out of NA, New Jersey.

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 11, 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.