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Job Title: Quality Specialist Job Description

We are seeking a dedicated Quality Specialist to join our dynamic team within a rapidly growing Cell and Gene Therapy CDMO at a brand new site. In this role, you will ensure compliance with quality objectives and regulatory requirements while supporting manufacturing and technical operations.

Responsibilities

+ Provide on-floor Quality Operations support for manufacturing, warehouse, and other technical operations, including in-process checks, deviation identification, and adherence to cGMP expectations.

+ Ensure all manufacturing activities comply with GMP and regulatory requirements.

+ Review and approve GMP documentation such as batch records, SOPs, test methods, validation protocols, and technical reports for accuracy and compliance.

+ Execute product-related activities, including apheresis material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment.

+ Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies.

+ Apply structured root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), and FMEA to support investigations.

+ Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.

+ Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.

+ Participate in and support internal audits, facility walkthroughs, and regulatory inspections.

Essential Skills

+ 3+ years of cell therapy experience.

+ 3-5 years of GMP manufacturing experience.

+ Experience in Quality Assurance oversight for manufacturing floors.

+ Proficient in ISO 7 gowning procedures.

+ 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.

+ Strong knowledge of batch record review, aseptic operations, and environmental monitoring.

+ Demonstrated ability to lead and close complex quality investigations including root cause analysis and development of effective CAPAs.

Additional Skills & Qualifications

+ CDMO experience is strongly preferred.

+ Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance.

+ Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, and FMEA.

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

+ Ability to understand technical concepts and make informed quality decisions in clinical manufacturing.

+ Willingness to work in ISO 7 environments for on-the-floor QA support.

+ Proactive, adaptable, and committed to continuous learning.

+ Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed.

Work Environment

Work at a growing CDMO specializing in Cell and Gene Therapy at a brand new site. This position requires working in ISO 7 environments and may involve varying work hours, including evenings, weekends, and shifts. The role involves being actively present on the manufacturing floor, supporting operational excellence and contributing to a collaborative team-oriented environment.

Job Type & Location

This is a Permanent position based out of NA, New Jersey.

Pay and Benefits

The pay range for this position is $75000.00 - $85000.00/yr.

40k medical dental vision

Workplace Type

This is a fully onsite position in Princeton,NJ.

Application Deadline

This position is anticipated to close on Oct 20, 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 [email protected] (%[email protected]) for other accommodation options.