What are the responsibilities and job description for the QC Analyst II, Quality Control Microbiology position at The Steely Group?
Reporting to the Associate Director of QC Microbiology, the QC Analyst II role will support the gene therapy program pipeline through the execution of GMP microbiological assays including, but not limited to, endotoxin, bioburden, total organic carbon (TOC) and growth promotion. Must be able to adapt and perform in a fast-paced environment, while still delivering high-quality results. The QC Analyst II will be required to have strong interpersonal skills and must be able to work under minimal supervision.Responsibilities:Performs routine Quality Control microbiology testing of product and water samples. Testing includes bioburden, plate reading, endotoxin, total organic carbon, conductivity and media growth promotion.Conducts review of GMP analytical data.Supports routine laboratory operations (data management, equipment cleaning, laboratory cleaning, inventory control and logbook management)Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.Revise SOPs, forms, protocols, data reports, and other controlled documents relating to QC microbiology testing and instrumentation.Performs peer review of both internal and externally generated data, as needed.Supports QC deviations, investigations, root cause analysis, change control, and CAPA as needed.Requirements / Qualifications:BS or MS in Microbiology or a related discipline with 2 years industry experience. QC GMP experience is required.Hands-on experience with performing microbiological analytical testing (bioburden, endotoxin, TOC, etc..) required.Independently motivated and detail-oriented with good problem-solving ability.Strong oral and written communication skills with clear penmanship. Proficient in the use of computerized systems.Experience with Excel and Microsoft Word.Ability and desire to work in a fast-paced, start-up environment.Strong collaboration skills.Shift: 9:30 AM – 6:00 PM, Monday – Friday. Flex hours and occasional weekend work.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
Salary : $45 - $48
