QC Manager/Sr. Manager

New

Skills

Communication Skills Data Analysis Problem-solving

Job Overview

As a Manager/Sr. Manager in Quality Control (QC), you will be responsible for overseeing analytical data for release, stability, and in-process testing at Contract Manufacturing Organizations (CMOs). Your role will involve managing labs, investigating out-of-specification and out-of-trend results, as well as deviations. Additionally, you will be required to follow up with labs to rectify deficiencies in test packages and submit them to Quality Assurance (QA). You will also need to load data into an electronic storage program, review data for reference standard qualification, method validation, and transfer. Some travel may be required to analytical testing sites.

Responsibilities
  • Review and analyze analytical data for release, stability, and in-process testing at CMOs
  • Oversee labs and manage investigations into out-of-specification, out-of-trend results, and deviations
  • Follow up with labs to correct deficiencies in test packages
  • Submit test packages to QA and load data into an electronic storage program
  • Review data for reference standard qualification, method validation, and transfer
Requirements & Qualifications
  • M.S./B.S. in life sciences; Chemistry/Analytical Chemistry preferred
  • 5+ years of experience in Quality Control in the pharmaceutical industry
  • 2+ years of management experience
  • Strong analytical skills and ability to work independently under deadlines
  • Detail-oriented with a sophisticated understanding of cGMP regulations
  • Ability to distinguish between regulated and non-regulated activities
  • Excellent communication skills to liaise with vendors on project scope, results, and updates

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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