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The Accuro Group Inc
Franksville, Wisconsin, US
Closing date
Dec 19, 2021

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Business Title: 2272 | Microbiologist

Location: Franksville, WI 53126

Job Type: Contract (12 M+)

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 the operation of the department and Quality System.

Job Requirements:

Job Responsibilities:
  • Assist with sterilization product and process validations as required to ensure 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 CLIENT Aesthetics Medical products
  • Support sterilization, product, process, environmental, and cleaning validations as required to ensure 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 were 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

Skills & Experience Required:
  • BS in Microbiology, Biology, Physical Science, or equivalent experience required
  • GLP/GMP experience is required
  • Pharmaceutical experience is preferred
  • Physical Demands/Environment:
  • Cleanroom work is required
  • Lifting of light (less than 15 pounds) objects
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