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Quality Control Lead

1 week ago

Durham, North Carolina, United States Piper Companies Full time

About the Role

We are seeking a highly skilled Senior Quality Control specialist to join our team in Durham, North Carolina.

This individual will be responsible for leading Contract Testing Laboratory management, cross-functional communications, control chart implementation, batch release testing, and authorship of certificates and laboratory investigations.

Responsibilities

  • Perform in-process, characterization, stability, and release testing as assigned, including HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP.
  • Coordinate with CTLs to ensure timely results, review lab investigations/quality records, and author data summaries and certificates.
  • Lead and review lab investigation and deviation reports, implement control charts for new programs, and assist department in CAPA implementation and resolution.

The ideal candidate will have a strong biochemistry background in biopharmaceutical analytical testing and excellent critical thinking and troubleshooting skills.

Requirements

  • B.S. degree with 6+ years of related experience, M.S. degree with 4+ years of related experience, or Ph.D. in a related scientific discipline with 1+ years of relevant experience.
  • Strong biochemistry background in biopharmaceutical analytical testing.
  • Excellent critical thinking and troubleshooting skills.

Why Work with Us

  • Competitive salary based on level of experience.
  • Comprehensive benefits package: Healthcare, Dental, Vision, 401K, and sick leave as required by law.