Supervisor QC Microbiology

Lead all daily operations of the QC Micro Department,Oversee and provide guidance to QC Analysts,Review and maintain accurate and compliant documentation and records,Participate in internal and external audits, investigations, and reporting,Provide technical expertise to the Micro team,Utilize problem-solving tools for root cause analysis and resolution,Operate within department budget, cost, and profitability restraints, ensuring materials meet regulatory requirements,Ensure timely response and closure of customer complaints,Conduct and lead effective meetings and communications,Prepare and facilitate reporting for QC Micro Leadership Team,Manage KPI performance, goals, and objectives,Issue and trace deviations, change controls, CAPAs related to QC Micro Department,Review and approve QC Micro data for accuracy and compliance with SOPs and Test Methods,Support and coordinate special projects and other assignments related to QC Micro Department,Ability to report onsite,Work flexible hours, split shifts, weekends, and holidays as required by business operations

Bachelor's degree in biology or relevant scientific discipline,3-4 years of relevant Microbiology experience preferred or equivalent combination of education and experience,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,Previous experience supervising/scheduling staff for a 24/7 operation desired,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,Excellent writing skills (drafting SOPs, protocols, reports, deviations, EM investigations, OOS reports, CAPAs),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, and cleanroom environmental monitoring,Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing, and Quality Assurance,Ability to multitask, problem solve, and troubleshoot as necessary

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