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QC Manager

Grand Rapids, MI

Posted: 09/25/2020 Job Number: JN -082020-11829

Job Description

QC Manager - Microbiology

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: QC Manager - Microbiology
Location: Grand Rapids, Michigan
Industry: Pharmaceutical
Hours: 1st Shift
Salary: $80-110k/yr.
Employment Type: Permanent

Job Summary:
Oversee the QC Microbiologists performing environmental monitoring, water testing and other clientspecific microbiology testing in support of aseptic manufacturing operations. Duties include, but are not limited to: oversight of analysts performing complex microbial analysis, review of microbiology test results, assistance with method development and validation work, oversight of contract laboratories performing microbiological analysis on behalf of client, monitoring facility / personnel performance with regards to contamination control, and investigation of out of trend / out of specification results.

Responsibilities:
  • Provide leadership to Quality Specialists of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
  • Oversee testing on water, materials, components, personnel and the environment to detect microorganisms and to obtain information on types and levels of microbial contamination.
  • Determine impact of microorganisms on processes / products and evaluate the effectiveness of contamination control strategies on the manufacturing environment.
  • Communicate the status of microbiological testing and results trending to QA, Manufacturing, Validation and other departments as needed.
  • Draft and review technical investigations, protocols and reports; offer conclusions and recommendations based upon study outcomes.
  • Actively participate in laboratory and environmental investigations and identify / assess corrective and preventive actions.
  • Draft, review and approve protocols, reports and procedures.
  • Perform method development and validation activities as required, including all associated protocols and reports.
  • Participate in quality audits of contract laboratories and other vendors to ensure third parties meet all requirements for qualification.
  • Oversee or coordinate the required contract testing of samples and manage the receipt of test results.
  • Establish and maintain good practices with regards to testing processes and data management.
  • Ensure that trending is performed on a routine basis and that periodic summaries are compiled, maintain laboratory logbooks and other documents to ensure GDP.
  • Develop training requirements, ensure all Microbiology personnel are adequately trained and qualified to perform the assigned job functions.
  • Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry best practice.
  • Support Agency, customer and vendor audits as needed.
Qualifications:
  • Candidate must have a minimum Bachelor s degree in scientific discipline
  • 8-10 years of work experience in a related field
  • At least 2 years of prior management / leadership experience required.
  • At least 2 years of prior experience in a parenteral manufacturing environment required.
  • Prior experience interacting with regulatory authorities is preferred.

EOE/ADA
Search words: Microbiologist, Microbiology, investigations, contaminination, microbial, environment, water testing, microorganisms, QC

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