Supervisor QC Microbiology

Lead all activities associated with daily operations of the QC Micro Department.,Oversee the performance of QC Analysts, providing support, guidance, coaching, and recognizing successes.,Review and maintain documentation and records for accuracy and compliance.,Prepare for and actively participate in internal and external audits, investigations, and reporting.,Provide direction and technical expertise to the Micro team.,Utilize common problem-solving tools and methodologies for root cause analysis and resolution.,Operate within the department budget, cost, and profitability restraints, ensuring materials meet regulatory requirements.,Ensure timely response and closure of customer complaints.,Conduct and lead meetings and communications effectively.,Prepare and facilitate reporting as requested by QC Micro Leadership Team.,Manage KPI performance, goals, and objectives.,Issue and trace necessary deviations, change controls, CAPAs related to QC Micro Department.,Review and approve QC Micro data for accuracy and compliance to applicable SOPs and Test Methods.,Support and coordinate special projects and other assignments related to QC Micro Department.,Ability to supervise and manage the schedule of Analysts.,Ability and desire to take initiative on department-wide improvement projects and drive to completion.,Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.,Ability to process large amounts of paperwork in a timely and efficient manner.,Experience with microbiology laboratory design requirements, setting up/equipping, and inventorying.,Experience in culturing microbes and use of various classical microbiology and biochemical techniques (e.g., gram stain, streak plate, spread plates).,Experience in data/statistical analysis, data trending, reporting results, and presenting data in group and client meetings.,Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc.,Ability to write deviations, Environmental Monitoring investigations, OOS reports, CAPAs.

Bachelor's degree in biology or relevant scientific discipline.,3-4 years of relevant Microbiology experience preferred, or equivalent combination of education and experience.,Previous experience supervising/scheduling staff for a 24/7 operation desired.,Working knowledge of Environmental Monitoring of Good Manufacturing Practices (GMP) cleanrooms.,Familiarity with compendial microbiological testing methods for sterility, mycoplasma, endotoxin.,Experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR).,Understanding of cGMP/GLP regulations and excellent GDP (documentation skills).,Familiarity with relevant FDA, EMA, ICH, USP, and EP guidelines and regulations associated with quality control of aseptic processes, biologic/cell therapies, environmental monitoring, and cleanroom operation.

Bachelor's Degree

Must be able to report onsite.,Work flexible hours, split shifts, during weekends and holidays as the operations of the business requires.