Published: October 25, 2018
- Supervise Microbiology Laboratory
- Oversee and conduct USP and EP microbiological analyses of raw materials, finished products, and environmental monitoring samples to include:
- OOS/Atypical results investigations.
- Troubleshooting Microbiological Methods application.
- Troubleshooting laboratory instrumentation.
- Train, coach, and mentor Microbiological staff.
- Write and cross-validate microbiological test methods for new and existing raw materials and finished products.
- Write Microbiology Laboratory Standard Operating Procedures (SOPs), trending reports, qualification protocols, method suitability reports, Aiken Bio-safety requirements, etc., that adhere to Corporate quality standards, Pharmacopoeia, and FDA guidelines.
- Provide and execute Performance Qualification support for plant utilities (i.e., USP Water, Nitrogen, Compressed Air, HVAC).
- Oversee the complete and scientifically sound resolution of out-of-specifications and atypical results.
- Troubleshoot and resolve issues relating to microbiological methods, processes, or equipment.
- Write and execute laboratory equipment qualification protocols (e.g., refrigerators, water baths, incubators, autoclaves, etc.)
- Review raw data, testing frequency, quality control specifications, and pharmacopoeial procedural revisions for correctness, compliance, and accuracy.
- Support Health Autories Audits (i.e FDA, EMA, MRHA, CAG, etc.)
- Bachelor’s Degree in Biology, Microbiology or related field.
- Minimum of 7 years’ experience in cGMP Laboratory environment, preferably as SME role
- Microbiology Subject Matter Expert (SME)
- Ability to manage multiple priorities
- Expertise in the use and operation of computers and related software (e.g., MS Office, LIMS, SAP)
- Take proactive measures to achieve goals
- Knowledge of cGMPs relating the QC Laboratory
- Working knowledge of particle counters, air sampling equipment, laboratory bio-safety, Quality Management standards, and GMP requirements.