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Amplify Bio - New Albany, IN

posted about 2 months ago

Full-time - Mid Level
New Albany, IN

About the position

The Sr. QC Associate, Microbiology at AmplifyBio plays a crucial role in ensuring the quality and safety of pharmaceutical products through microbiological testing and environmental monitoring. This position involves performing routine sampling and testing, contributing to laboratory maintenance, and collaborating with management to improve QC operations. The role requires adherence to FDA Good Manufacturing Practices and effective communication of results and procedures.

Responsibilities

  • Perform routine environment and utilities monitoring sampling and testing.
  • Conduct microbiological test procedures (e.g. sterility and bioburden) for GMP in-process and product lot release.
  • Contribute to the QC laboratory maintenance and lab operations systems.
  • Work with QC management on the continuous improvement of QC operations procedures and systems.
  • Communicate clearly and concisely, both verbally and in written reports, including drafting protocols and revising laboratory procedures.

Requirements

  • Bachelor's degree in relevant biological sciences (Microbiology degree preferred).
  • 5+ years of experience in the pharmaceutical or biotechnology industry laboratory or in an academic laboratory.
  • Hands-on experience with microbiology, environmental/utilities/personnel monitoring methods, such as air sampling, growth promotion, microbial identification, and/or sterility testing.
  • Ability to excel in a fast-paced team environment and handle multiple tasks concurrently.

Nice-to-haves

  • Experience in a dynamic and cooperative environment that is goal-driven.
  • Dedication to mentoring team individuals and motivating team success.

Benefits

  • Health, Dental, and Vision insurance starting on the first day.
  • Competitive Compensation Package.
  • Flexible PTO policy for work-life balance.
  • Generous paid parental leave.
  • Wellness and Self-Care Programs.
  • 401(k) match.
  • Tuition Reimbursement.
  • EAP/work-life support system.
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