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Quality Control Analyst - Microbiology - Cellular Therapy - Nights
Raritan, NJ 08869 US
Job Description
Looking for QC Analysts with a background in Microbiology working on Cellular or Genetic Therapies. Direct Hire only with world class benefits! Sorry - no visa transfers or sponsorship at this time.Â
Rapidly growing GMP facility for CAR-T cellular therapy.
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!
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The Microbiology CAR-T Manufacturing QC Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and endotoxin testing. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and cGMP regulations. They typically work with a team of 5 – 15 other Associates within the functional Quality Control laboratory and the Manufacturing area.
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Key Responsibilities:
- Participate in CAR-T manufacturing facility commissioning and qualification.
- Perform compressed gas sampling and Routine Environmental Monitoring of classified areas within the Raritan CAR-T manufacturing facility.
- Perform endotoxin testing.
- Participate in gown qualification and requalification of personnel.
- Create, review, and approve relevant QC documents, SOPs, and WIs.
- Support Aseptic Process Simulations and visual inspection of components.
- Utilize electronic systems (eLIMS) for execution and documentation of testing.
- Perform peer data review/approval of laboratory data.
- Initiate quality investigations related to environmental monitoring.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
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 Qualifications
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Education:
- Minimum of a Bachelor’s or equivalent University degree required; focused degree in Biological Science or equivalent technical field preferred
Experience and Skills:
Required:
- Minimum two (2) years of relevant work experience
- Experience within the biological and/or pharmaceutical industry
- Microbiology experience related to manufacturing
- Detailed knowledge of Microbiology testing and sampling methods, techniques, and related equipment
- Aseptic processing in ISO 5 cleanroom
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
- Excellent written and verbal communication skills
- Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision
Preferred:
- Knowledge of Microbiology laboratory techniques such as endotoxin testing, sterility testing, bioburden testing, growth promotion testing, and/or microbial isolation
- Experience working with cell therapy
- Knowledge of FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices (GTP)
- Trending using statistical analysis
Other:
- Requires ability to work in an aseptic processing environment (ISO 7 or ISO 8) and adhere to cleanroom gowning procedures
- Requires ability to occasionally lift up to 20 lbs
- Requires flexibility and ability to work available 10-hour shifts, including providing support on the weekends or other shifts and accommodate unplanned overtime on little to no prior notice; shifts include: 2:00pm - 1:30am (Sunday - Wednesday), 2:00pm - 1:30am (Wednesday - Saturday), 7:00am - 5:30pm (Sunday - Wednesday), and 7:00am - 5:30pm (Wednesday - Saturday)
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The anticipated base pay range for this position is $60,000 to $96,600. This position is eligible for a shift differential (15%) when working the night shifts.
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.