Microbiologist
Job Description: Supports all activities related to microbiological assessment of products and the manufacturing environment. Advise Quality Assurance, Manufacturing and R&D departments on matters related to product sterilization and microbial assessment. Evaluate the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance to quality standards and regulations and recommend where corrections or improvements are indicated.
Supports root cause analysis for nonconformity and/or out of specification events. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System.
- Essential Duties and ResponsibilitiesAssist with sterilization product and process validations as required to insure product quality and Quality System requirements are met.
- Coordinate and maintain associated databases for all microbiological data and provide support to other departments as required.
- Perform quality review for microbiological testing/monitoring data .
- Maintain a high level of expertise in current regulatory requirements, including FDA Quality System Regulations, and ISO standards.
- Write, revise and review related Standard Operating Procedures (SOPs) and Department related Protocols.
- Perform root cause analysis for microbial excursions and other microbiology investigations.
- Participate in audits and as part of cross-functional teams with other functional areas and facilities as an SME (Subject Matter Expert).
- Write and reviews investigations of microbial excursions and other microbiology investigations.
- Monitor microbiological trends in their respective areas and responds appropriately.
- Monitor the manufacturing and quality assurance activities associated with the sterilization of Merz Aesthetics Medical products
- Support sterilization, product, process, environmental and cleaning validations as required to insure product quality and Quality System requirements are met.
- Coordinate and analyze databases associated with oversight of product and process sterilization and its reporting process. Provide Corrective Actions where indicated.
- Provide product sterilization and microbiological assessment support to the Manufacturing, R&D, and other departments.
- Assist with continued company certification to the appropriate quality system standards and regulations, and assist with all related inspections..
- Provide backup in reviewing and approving internal operating procedures and specifications.
- Provide assistance to the Regulatory Affairs department as required.
Education and/or Experience:BS in Microbiology, Biology, Physical Science or equivalent experience required.
- Fresh Microbiology or Biology graduates ideal.
- Experience in Microbiological, Biological, Quality Assurance and/or other regulated industry or similar experience preferred but not required.
- GLP/GMP experience is preferred.
- Physical Demands/Environment
- Clean room work is required.
- Lifting of light (less than 15 pounds) objects.