Microbiology Analyst III

The Microbiology Analyst III is responsible for developing procedures, performing investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. YOU MUST BE ABLE TO WORK ON-SITE IN MOUNT LAUREL, NJ. Salary Starting at $30 hourly depending on experience plus 2 bonuses per year. Essential Duties and Responsibilities include the following. Other duties may be assigned. Perform method development and validation for sterility, bioburden, endotoxin, particle size distribution of products including, but not limited to, injections, ophthalmic preparations, oral tablets, oral liquids, raw materials, and components Perform method development and validation for rapid sterility and bioburden test methods, specifically using ATP bioluminescence detection Perform method development and validation for Antimicrobial Effectiveness Testing (AET) for sterile and non-sterile finished product Perform and/or assist in investigations Perform/review/approve, lead and schedule routine analysis of finished product, raw material, and components according to established specifications and procedures relating to: Sterility Bioburden Endotoxin AET Particulate Matter Container Closure Particle Size Distribution Water Activity Perform atypical particulate inspection and prepare report Performs/reviews/approves media qualification (Sterility and promotion) and perform QC release Support microbiological testing on facility water (WFI, CS, etc.) and biological indicators Review and approve data related to testing Support writing, review, and approval of protocol, standard operating procedure, work instructions, and reports for client Support developing new projects and methods Performs technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities Prepare, review, and approve inhouse media, reagents, and test samples as required Prepare microorganisms for identification, perform/review Gram staining. Perform and interpret microbial identification results Performs/reviews sample receipt, manages and disposes analyzed samples as needed Perform/review and maintain laboratory and equipment cleanliness Must be proficient in training new and existing employees Understand and demonstrate aseptic technique Proficient in membrane filtration in relation to sterility and bioburden testing Maintains laboratory supply inventory and re-order as needed Perform root cause analysis and determines and implements corrective actions for errors and issues as necessary Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory as needed Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice) Support audits by regulatory agencies, such as FDA, BOP and DEA Required Education and Experience #J-18808-Ljbffr Epicur