Microbiologist

Location: Orangeburg

QA Microbiologist II Book here for more information: ((Use the "Apply for this Job" box below).) The QA Microbiologist II performs microbiological testing and analysis of raw materials, pharmaceutical products, environmental samples, and finished products while ensuring data integrity, cGMP compliance, and appropriate product release. This role supports laboratory equipment maintenance, technician training, investigations, procedures, and microbiology-related projects, contributing directly to the quality and safety of pharmaceutical products in a highly regulated environment.

Responsibilities + Conduct routine microbiological testing for water, bulk pharmaceutical chemicals, drug products, and finished products, and assess results according to approved test methods and work instructions. + Perform method suitability testing on finished products using traditional microbiological methods, document results clearly, and report findings in accordance with procedures. + Sample and test water, environmental air, and surfaces, then analyze, report, and trend data to support environmental monitoring programs.

+ Conduct aseptic sampling for evaluation of compressed air and cleaning and sanitization processes to verify control of the manufacturing environment. + Perform basic identification of microorganisms to support product quality investigations and environmental monitoring assessments. + Prepare microbiological media used in testing bulk pharmaceutical chemicals, drug products, and components, ensuring suitability for intended use. + Perform growth promotion testing for purchased and prepared media to confirm performance and reliability.

+ Sample raw materials and finished products aseptically for microbial testing, following strict aseptic technique and cGMP requirements. + Assist in the maintenance, calibration, and certifications of laboratory equipment to ensure accurate and reliable testing. + Train and qualify technicians and microbiologists on testing procedures and techniques, and oversee data entry into electronic systems or laboratory notebooks. + Review data generated by microbiologists in a timely manner and ensure ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) are consistently applied.

+ Collaborate with third-party laboratories to ensure specifications are communicated, results are received, reviewed, and processed appropriately. + Support LIMS-related activities and special projects specifically focused on microbiology and laboratory process improvements. + Write scientifically sound microbiology investigation reports, non-conformance evaluations, and root cause investigations that meet regulatory and internal standards. + Write or update Standard Operating Procedures (SOPs) to ensure they remain current and compliant with regulatory requirements and industry best practices.

+ Ensure all laboratory activities maintain compliance with current Good Manufacturing Practices (cGMP), cleanliness standards, and data integrity requirements at all times. + Prepare samples for shipment to external contract laboratories for microbiological testing, ensuring proper documentation, packaging, and chain of custody. + Participate in investigations, non-conformance assessments, document revisions, and technical writing activities to support continuous improvement and upskilling.

Essential Skills + Bachelor's degree in Biology, Microbiology, Chemistry, or a related science from an accredited college or university. + A minimum of 3 years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience. + Strong understanding of Current Good Manufacturing Practices (cGMP) and Food and Drug Administration (FDA) regulations relevant to pharmaceutical microbiology.

+ Proficiency in traditional microbiology techniques, including gram staining, streak plating, culture maintenance, and aseptic techniques. + Knowledge of United States Pharmacopeia (USP) chapters related to microbiology, including USP , USP , and USP . + Ability to perform gram staining and aseptic techniques accurately and consistently in a regulated laboratory…