QC Analyst II, Quality Control Microbiology

Innova Solutions•Woburn, MA

8d•Onsite

About The Position

Innova Solutions has a client that is immediately hiring for a QC Analyst II, Quality Control Microbiology. This is a Full Time Contract position with a duration of 6 months, located in Woburn, MA. 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.

Requirements

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.
Proficient in the use of computerized systems.
Experience with Excel and Microsoft Word.

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.