The QA Microbiologist is responsible for leading/performing activities necessary for implementation of Microbiology Support of product commercialization/technical transfer. These activities include guidance and review of method validations/ transfers, implementation of new methodology, provide training to Microbiology Staff and provide troubleshooting for methods utilized in Microbiology. In addition to these responsibilities, the QA Microbiologist will assist in conducting/reviewing lab investigations, and document reviews and updates. Responsibilities: + Provide oversight for transfer/commercialization projects for Microbiology. Responsible for reviewing microbiology method summary reports. + Assist in writing and revising laboratory SOPs, method validation/transfer protocols and summary reports. + Responsible for assisting Microbiology with lab investigations, reviewing deviations and ensuring timely closure to meet deadlines and product release dates. + Perform trending and write or review summary reports as needed. + Assist with implementation of contamination control planning and maintenance. + Assist with CAPA creation, review and closure. + Responsible for performing any special projects as assigned to include timely completion. + Perform training when needed to staff regarding Microbiology activities. + Follow Standard Operating Procedures, safety, health, and cGMP Guidelines. Qualifications: + BS degree in Biology or Microbiology with a minimum of 4 years of experience in a pharmaceutical laboratory or an advanced degree with 2 years of experience in a pharmaceutical laboratory. + Proficient with current word processing, spreadsheets, and database software. + Knowledge of operational processes and controls in sterile pharmaceutical manufacturing + Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships with other departments. + Ability to think strategically and be detail-oriented Qualifications