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Senior Supervisor Quality Control Release - Nights
Raritan, NJ 08869 US
Job Description
Direct Hire - Great Benefits - 15% shift differential - Annual Bonus and MORE!
10-hour shifts between the operational hours of 2:00pm - 1:30am (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!
The QC Senior Supervisor is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. They will also support internal and external audits. They will typically guide daily work activities of 10-12 direct staff within a functional laboratory of the Quality Control department. They are responsible for interviewing, hiring, performance review, rewarding and disciplining employees, addressing complaints, and resolving conflict.
Key Responsibilities:
- Manage analyst schedule to support Drug Product testing
- Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
- Review/approve documents as a QC department subject matter expert (SME)
- Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
- Ensure accuracy and completeness of executed analytical method transfer activities
- Set testing priorities and manage work assignments
- Mentor, train, and supervise quality control staff, as well as evaluate performance and provide opportunities for growth
- Communicate department objectives and metrics
- Support internal and Health Authority audits, as well as audit related investigations
- Minimum of a Bachelor’s or equivalent University degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, or related scientific field is preferred
Required:
- Minimum 6 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
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
- Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing
Preferred:
- Proficient knowledge of analytical technologies used in a Quality Control laboratory and method transfer
- Experience leading, coaching, or supervising direct or indirect personnel or teams
- Work experience in Cell and/or Gene Therapy or Biologics
- Experience with LIMs and SAP or equivalent systems
- Requires ability and flexibility to work 10-hour shifts between the operational hours of 2:00pm - 1:30am (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)
- Requires up to 5% domestic travel to other sites/locations
The anticipated base pay range for this position is $88,000 to $142,600. This position is eligible for a shift differential (15%) when working the night shifts.
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.