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Urgent! Quality Specialist Job Opening In Princeton – Now Hiring Actalent
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 27, 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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Unlock Your Quality Specialist Potential: Insight & Career Growth Guide
Real-time Quality Specialist Jobs Trends in Princeton, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Quality Specialist in Princeton, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 133779 jobs in United States and 133 jobs in Princeton. This comprehensive analysis highlights market share and opportunities for professionals in Quality Specialist roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Actalent is currently hiring and seeking a Quality Specialist to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Quality Specialist Jobs Princeton.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Actalent adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Quality Specialist Jobs United States varies, but the pay scale is rated "Standard" in Princeton. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Quality Specialist typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Quality Specialist interview at Actalent, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Actalent's products or services and be prepared to discuss how you can contribute to their success.
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