QC Microbiology Analyst

Insight Global is seeking a QC Microbiology Analyst to work onsite at one of our largest pharmaceutical companies in Sanford, NC. This position is focused on Microbiological assays focusing on cell bank testing (e.g. culture purity, viable count method (serial dilution), growth suitability, microbial identification, serotype identity (agglutination) testing). Analyst would be a Laboratory Analyst responsible for ensuring release and routine stability testing of cell banks is completed, within the required time frame. Other responsibilities could include: Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance Responsible for appropriate creation of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. Standard Operating Procedure (SOP) revisions, qualification/validation support, leading/participating in projects. Must haves: Applicant must have bachelor’s degree in with 3 years of relevant experience Experience with testing in the lab (cell culture, growing and fermenting cultures), stability and release testing Experience with purity testing, viability, suitability of growth, streaking and isolating colonies, media making, Bioburden, water testing (do not have to have all of these – but at least several) Experience in QC or R&D GMP laboratory within pharma Experience / Knowledge of LIMS, PDOCS, gQTS, eQMS