Similar posts
Quality Control Investigation Specialist
- Contract
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)
- United States
Proclinical is seeking a Quality Control Investigation Specialist for a global biotech company located in Raritan, NJ.
The QC Investigations Specialist, CAR-T Manufacturing is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Must be eligible to work in the US.
Job Responsibilities:
- Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
- Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
- Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.
- Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders.
- Work closely with management to propose/execute improvements through the change management system.
- Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.
- Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Skills and Requirements:
- Minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
- Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
- Minimum of 2 years of Quality Control experience is required.
- Minimum of 2 years of experience with leading investigations is required.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is a plus.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- Excellent written and oral communication skill are required
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 10% domestic or international travel as business demands.
If you are having difficulty in applying or if you have any questions, please contact Kylie Williams at +(1) 267-523-2542 or k.williams@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-KW1
INDCQA
Related jobs
Highly Competitive Salary
Tempe, USA
Proclinical is seeking a remote Clinical Quality Consultant for a cutting-edge biotech company.
Up to US$47 per hour + Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a Quality Control Sterility Analyst for a cutting-edge biotech company located in Philadelphia, PA.
Highly Competitive Salary
Miami, USA
Proclinical is seeking a Director of Compliance for a cutting-edge medical clinic located in Miami, FL.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a Quality Control Analyst, Deviations for a cutting-edge biotech company located in Philadelphia, PA.
£100000 - £110000 per annum
Slough, England
Proclinical are recruiting for a Head Global Quality Audit to join a biotech organisation. This role is on a permanent basis and can either be located in the UK or France.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a QC Analyst Environmental Monitoring for a cutting-edge biotech company. This role is on a contract-to-permanent basis on-site in Philadelphia, PA.
Highly Competitive Salary
Burlington, USA
Proclinical is seeking an Associate Director, Upstream Process Development for a cutting-edge biopharmaceutical company located in Burlington, MA.
Highly Competitive
Hatfield, England
Proclinical are recruiting for a QC Microbiologist (9 Month FTC) to join a pharmaceutical organisation. This role is on a permanent basis.
Highly Competitive Salary
Hunt Valley, USA
Proclinical is seeking a Principal Scientist, R&D-Aseptic Development for a leading pharmaceutical company located in Hunt Valley, MD.
Highly Competitive Salary
Hunt Valley, USA
Proclinical is seeking a Director of Formulation & Transfer for a leading pharmaceutical company located in Hunt Valley, MD.