Quality Control Technician

Actalent • Princeton, NJ • 3h ago

Job Title: Quality Control TechnicianJob Description

We are seeking a detail-oriented and motivated Quality Control Technician to join our microbiology team supporting cell therapy manufacturing. This role will focus on environmental monitoring (EM), microbiological testing, and routine lab operations to ensure product and facility compliance with GMP standards.

Responsibilities

Perform environmental monitoring (EM) of cleanrooms, including air sampling, surface sampling, and personnel monitoring.

Conduct microbial plate reading and identification of colony morphology.

Execute bioburden and endotoxin testing on raw materials, in-process samples, and final products using validated methods.

Perform pipetting and sample preparation for microbiological assays with precision and accuracy.

Maintain and calibrate laboratory equipment and ensure proper documentation of all activities.

Support routine QC microbiology testing in accordance with SOPs and regulatory requirements.

Document results in laboratory notebooks and electronic systems, ensuring data integrity and compliance.

Assist in investigations related to out-of-specification (OOS) results or environmental excursions.

Participate in the qualification and validation of microbiological methods and equipment.

Maintain inventory of microbiology supplies and reagents.

Support audit readiness and participate in internal and external inspections.

Essential Skills

Associate's or Bachelor's degree in microbiology, biology, or related life sciences field.

1 year of experience in a GMP-regulated QC microbiology lab, preferably in cell therapy, biologics, or pharmaceuticals.

Familiarity with aseptic techniques and cleanroom operations.

Experience with EM, bioburden, endotoxin testing, and microbial identification.

Strong attention to detail and ability to follow SOPs precisely.

Good documentation practices and understanding of data integrity principles.

Ability to work in a fast-paced, team-oriented environment.

Additional Skills & Qualifications

Experience with LAL endotoxin testing (gel clot, kinetic chromogenic, or turbidimetric methods).

Familiarity with rapid microbiological methods or automated systems.

Knowledge of regulatory guidelines (USP , , , , FDA, EU).

Bachelor's degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry.

5-7 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics.

Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, FMEA, and other risk-based quality tools.

Excellent problem-solving skills, with a focus on risk-based decision-making and continuous improvement.

Ability to manage multiple priorities and thrive in a dynamic environment.

Work Environment

The position is based in a growing CDMO - Cell/Gene Therapy at a brand new site. The work environment includes ISO 7 cleanroom conditions requiring gowning. The role involves being on the manufacturing floor, providing quality oversight, and supporting problem-solving across QC, QA, manufacturing, and warehouse operations. Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed, is required. The team-oriented environment encourages continuous learning and operational excellence.

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 - $26.00/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 Sep 1, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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