Microbiologist

Microbiologist Jr Location: 4133 Courtney St. Franksville, WI, Pay rate: $21/HR Supports all activities related to microbiological assessment of products and the manufacturing environment. Advises Quality Assurance, Manufacturing and R&D departments on matters related to product sterilization and microbial assessment. Evaluates the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance to quality standards and regulations and recommends where corrections or improvements are indicated. Supports root cause analysis for nonconformity and/or out of specification events. Provides direct support to Quality Assurance personnel regarding operation of the department and Quality System. Quality Testing Perform Endotoxin and Bioburden testing per established procedures. Perform Environmental Monitoring (EM) of the Cleanrooms as required. Perform quality analysis of the water systems for the manufacturing sites as required. Documentation Perform quality review for microbiological testing/EM monitoring data. Coordinate and maintain associated databases for all microbiological data and provide support to other departments as required. Monitor microbiological trends in their respective areas and responds appropriately. Write, revise and review related Standard Operating Procedures (SOPs) and Department related Protocols. Perform root cause analysis for microbial excursions and other microbiology investigations. Write and review investigations of microbial excursions and other microbiology investigations. Monitor the manufacturing and quality assurance activities associated with the sterilization of Medical products. Validation Support Assist with sterilization product and process validations as required to insure product quality and Quality System requirements are met. Regulatory Support Maintain a high level of expertise in current regulatory requirements, including FDA Quality System Regulations, and ISO standards. Participate in audits and as part of cross-functional teams with other functional areas and facilities as an SME (Subject Matter Expert). Manufacturing Support Support sterilization, product, process, environmental and cleaning validations as required to insure product quality and Quality System requirements are met. Education and/or Experience (years)

1. BS in Microbiology, Biology, Physical Science or equivalent experience required.
2. 1-2 years' experience in Quality Laboratory, preferred.
3. GLP/GMP experience is preferred.
4. Pharmaceutical experience is preferred.

Physical Demands/Environment Clean room work is required. Lifting of light (less than 15 pounds) objects. AA2IT