Responsibilities/Requirements
Responsible for QC microbiology environmental monitoring, utility monitoring, disinfectant qualification, and Microbial Data Deviation (MDD) investigation procedures/programs to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, using the clients' processes and procedures. Responsibilities are expected to include but are not limited to:
Establish a cleanroom qualification program (EMPQ) by authoring the study protocol, report, and associated risk assessment documents. Perform trending of EM data.
Support establishment of a routine EM program by authoring risk assessment documents to establish routine sampling points.
Establish a clean utility qualification program by authoring the study protocol, report, and associated risk assessment documents. Perform trending of data.
Establish a disinfectant efficacy qualification by authoring a risk assessment, study protocol and report.
Author microbiology technical documents, including but not limited to a site Contamination Control Strategy (CCS), OOS/Microbiology Data Deviation (MDD) Investigation, cleanroom gowning procedure, and management of in-house isolates.
Review microbiology SOPs for compliance with regulatory standards.
Experience
Experience working in an FDA-regulated biotechnology or pharmaceutical company is required with microbiology and environmental monitoring experience.
Knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, biological indicators, environmental monitoring, etc.
Knowledgeable with USP/EP and FDA/EMA GMP regulations.
Strong communication skills (written and verbal).
Strong analytical and problem-solving ability.
Hands-on approach, with a 'can do' attitude.
Ability to prioritize, demonstrating good time management skills.
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module.
Employment Type: Contractor
Salary: $ 40.00 45.00 Per Hour
