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Senior Quality Control Analyst, CAR-T Analytics
Raritan, NJ 08869 US
Job Description
Senior Analyst - QC Analytics - Day Shift
Direct Hire - Great Benefits + Annual Bonus and MORE!
10-hour shifts between the operational hours of 8am - 6pm (Wednesday - Saturday or Sunday - Wednesday), and provide occasional support on the weekends or other shifts
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!
The Senior QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 15 other Analysts within the functional laboratory of the Quality Control department.
Key Responsibilities:
- Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
- Perform peer review/approval of laboratory data and logbooks
- Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
- Build, review, and approve relevant QC documents, SOP’s, and WI’s
- Train new laboratory personnel
- Complete invalid assay and general laboratory investigation records, CAPAs, change controls
- Support Health Authority inspections
- Provide input to functional laboratory meetings
Education:
- Minimum of a Bachelor’s or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred
Experience and Skills:
Required:
- Minimum four (4) years of relevant work experience
- Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
- Experience within Biopharmaceutical or Pharmaceutical industry
- Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
- Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
- Experience with Quality Control document reviews and regulatory inspection processes
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
- Excellent written and verbal communication skills
Preferred:
- Work experience in Cell and/or Gene Therapy or Biologics
- Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
- Experience with LIMs and SAP or equivalent systems
- Experience, training, or certification with Process Excellence tools and methodologies
Other:
- Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Wednesday - Saturday or Sunday - Wednesday), and provide occasional support on the weekends or other shifts
- Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
- Requires up to 5% domestic travel to other sites/locations
The anticipated base pay range for this position is $73,000 to $117,300.
Job Requirements
Meet Your Recruiter
Sean Goulding
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance
Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.