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Sr Specialist, Quality Control-Microbiology

Kyowa Kirin North America
Location
Sanford, NC
Posted
1 month ago
Department
Quality Assurance
Salary
$116,000 to $152,300
What they actually want (must-haves)
  • Bachelor’s degree in Microbiology, Biotechnology, or life sciences
  • At least 5 years of experience in Quality Control Microbiology laboratory
  • Experience providing technical and compliance leadership within GxP Biopharmaceutical Manufacturing operations
  • Expertise in microbiological methods and procedures in a GxP environment
  • Proficient in MS Office Suite and Lean Labs or Agile Lean
Nice to have
  • Master’s degree in Microbiology or related life science
  • Experience leading investigations of microbial contamination incidents
  • Experience with starting up a new facility
  • Experience reviewing and contributing to Engineering Plans and GxP documentation
What the job really is

The Sr Specialist, Quality Control-Microbiology will lead the establishment and operations of the Quality Control Microbiology Laboratory at Kyowa Kirin's new manufacturing facility in Sanford, NC. This role involves ensuring compliance with GxP standards, providing technical leadership, and collaborating cross-functionally during the facility's start-up and operational phases. The specialist will also be responsible for training team members, managing laboratory processes, and overseeing quality metrics to support the production of monoclonal antibody products.

Benefits
  • 401(k) with Company Match
  • Annual Bonus Program
  • Generous PTO and Holiday Schedule
  • Sick Days
  • Volunteer Days
  • Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
Things to weigh
  • Initially working on a construction site before transitioning to a biotech manufacturing site
  • Work is 100% on-site; this is not a hybrid or remote role
  • Requires up to 10% domestic and limited international travel
Job score4.4/5
Benefits5/5
Freshness3/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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