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Senior Manager Microbiology & Sterility

  • Job type Permanent
  • Salary US$160000 - US$200000 per annum
  • Location Canton, Massachusetts
  • Sector Quality Assurance (QA)

Pharmaceutical Company for a Senior QC Microbiology & Sterility Manager opening in Canton MA. This site manufactures biologics products.

As the Senior Manager of Microbiology & Sterility QC you will be managing a team of 5 analysts to provide guidance and support. They are responsible for performing environmental monitoring, microbiological testing of water, utilities, product etc. As well as bioburden and endotoxin testing.

As the Senior Manager you will be developing and improving micro and sterility programs for the site including environmental action committees, deviations/change controls, disinfective effectiveness, data trending and managing.

Responsibilities:

  • Data Integrity - accountable for testing of microbial testing, utilities/environmental monitoring and in-process/final product microbiology samples.
  • Assures that the QC Microbiology laboratory operations are appropriately staffed and trained/cross-trained to meet both internal and external compliance (cGMP) requirements.
  • Manage, develop and maintain the Environmental Monitoring Program and prepare quarterly and annual trend reports and provide suggestions for continuous improvement.
  • Accountable for managing the sterility assurance program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents, local procedures and Emergent Global standards. This includes method conducting equipment and method Validation/Verification as appropriate
  • Ensure the Microbiology laboratories remains current with all changes to applicable compendia and ability to implement changes in a timely manner.
  • Review and approve technical protocols and reports.
  • Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigations and deviations.

Requirements:

  • Bachelor's Degree in microbiology or similar function
  • 3 years of people management experience
  • Detailed understanding of microbiology & sterility programs in an aseptic pharmaceutical GMP environment to include environmental monitoring, sterility assurance and data trending.

Salary up to $200K + bonus + equity. If you are interested and meet the requirements please apply with your resume and Real Staffing will reach out to discuss

Sthree US is acting as an Employment Agency in relation to this vacancy.