We are seeking a skilled Senior Quality Control Microbiologist to join our team. The candidate must be an SME in microbiological laboratory techniques and have extensive experience supporting an Environmental Monitoring program including the writing of EM Trend reports and assisting with EM Excursion Investigations.
•Analyze and Trend EM data
•Take ownership and write EM trend reports (Quarterly, Annual), Perform Trend analysis
•Take ownership and write EM Excursion Investigation reports, OOS and OOT investigations
•Create and Maintain database of EM data tracking and trending
•Use Quality Systems as necessary, including: Deviation, Change Control, CAPA
•Coordinate and work with vendors to schedule testing requirements and turnaround time commitments
•Conducts routine and non-routine analysis of microbiology methods in accordance with standard operating procedures (SOPs) or compendial methods
•Performs Method development/method transfer/method verification of microbial assays
•Updates or revises SOPs and other controlled documents as required
•Work on individual projects independently without supervision
•Maintains close communication and interaction with QC management and staff to ensure on-time testing
•Perform other related duties and tasks as required or assigned
•BS degree in Microbiology, Biology, Science (or related field)
•10 plus years of Microbiology experience in a GMP regulated environment required
•Knowledge of biological and /or chemical assays. Expert understanding of aseptic techniques and microbiology test methodologies
•Experience in performing Method development/method transfer/method verification of microbial assays
•Proficient with word processing and data spreadsheet software, such as MS Office (particularly MS Excel)
•Experience in an ISO and GMP/GLP qualified lab environment, an understanding of statistical data analysis, statistics is a plus.
•Strong written and oral communication skills, must be able to communicate effectively as well as follow written and verbal instruction. Strong collaboration skills as this role will cooperate with coworkers within an organized team environment. Manage time effectively to complete assignments in expected time frame.