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Senior Quality Control Analyst
Raritan, NJ 08869 US
Job Description
Requires ability and flexibility to work 10-hour shifts between the operational hours of 8am - 6pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
The Senior QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of raw
materials/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
- Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC
- laboratories
- Work with Process Development team, Quality, and Operations organization to successfully transfer
- process/analytical testing to cGMP facility to manufacture products.
- Perform peer review of laboratory data and logbooks.
- Utilize electronic systems (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
Qualifications
Education:
Minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific
field is required; advanced degree (MSc., Ph.D.) preferred
Skills & Experience:
Required:
- Minimum 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
- 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
? Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00 AM - 6:00
PM (Sunday through 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
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.