QC Microbiology Team Lead

QC Microbiology Team Lead

Location:
NC

Position Id:
19918

QC Microbiology Team Lead

A forward-thinking CDMO in the Raleigh-Durham area is seeking a QC Microbiology Team Lead. We're searching for a working manager of QC Microbiologists with excellent communications and release testing lab experience who possesses 4 to 8 years of QC leadership in investigation responses to OAL’s and OOS’s. Leadership experience and guidance of junior analysts is a must. This role has a very competitive salary and the ideal candidate will need to meet the qualifications below.

Summary Qualifications:

  • The ability to communicate on multiple levels in a matrix, fast-paced environment
  • Collaborative nature with excellent attention to detail and organizational skills
  • Ability to champion quality procedures and processes
  • SME knowledge of micro release testing methods, media qualifications, methods transfer, and validation.
  • Expert knowledge in Environmental Monitoring / Utilities Monitoring and GMP’s,
  • Knowledgeable in troubleshooting, batch review, FDA, USP and CFR regulations/guidelines
  • Proficient in data review, trending, tracking and reporting

Requirements:

  • BS or MS in Biological Science
  • 10 to 15 years of pharma / biotech experience

Finding the right person for this role is urgent in nature, so If you are qualified and serious about learning more about the opportunity, please apply with your most current resume.

Key Words:

Environmental Monitoring, Bioburden, Endotoxin, Microbial ID, Investigations, CAPA, validation, method transfer, sterility, media qualification, root cause analysis, LIMS, SME, CRO, CDMO, Contract Research Organization, Contract Development and Manufacturing Organization, Subject Matter Expert, Microbiologist, Microbiology

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