Quality Assurance Manager

4 weeks ago

Charles City, Iowa, United States Cambrex Full time
Job Summary

Cambrex is seeking a highly skilled Quality Assurance Manager to provide supervisory oversight and technical leadership for laboratory staff. The successful candidate will be responsible for directing the laboratory workflow, ensuring compliance with regulatory requirements, and providing on-going support for laboratory activities.

Key Responsibilities
  • Coordinate Laboratory Operations: Direct the daily prioritization of laboratory testing, including staff and equipment utilization, to ensure efficient and effective laboratory operations.
  • Maintain Laboratory Instrumentation: Ensure the maintenance of laboratory instrumentation, including equipment qualification and preventative maintenance programs, to ensure accurate and reliable test results.
  • Support Staff Development: Provide training and troubleshooting support for laboratory staff to ensure they have the necessary skills and knowledge to perform their duties effectively.
  • Review and Release Data: Review completed laboratory testing to support the timely release of data, reports, and materials, ensuring compliance with regulatory requirements.
  • Coordinate Offsite Testing: Coordinate and oversee the status of offsite sample testing to ensure timely and accurate results.
  • Maintain Compliance: Maintain and manage cGMP and general lab systems at defined levels of compliance, ensuring that all laboratory activities are conducted in accordance with regulatory requirements.
  • Draft and Review Documents: Draft and review various documents in support of laboratory efforts and production campaigns, ensuring that all documentation is accurate and compliant.
  • Provide On-Call Support: Provide on-call support coverage for all aspects of laboratory operation, including environmental testing, raw material testing, in-process testing, isolated intermediate testing, and finished good product release.
  • Collaborate with Cross-Functional Teams: Work cross-functionally with other departments, such as Operations/Production, to ensure deliverables are met according to projected timelines.
  • Verify Timecards and SAP Billing: Verify timecards and SAP billing is completed accurately and on time, as per site-specific timelines.
  • Perform QC Release: Perform the QC release for raw materials, isolated intermediates, and finished goods, ensuring that all products meet regulatory requirements.
  • Identify and Investigate Discrepancies: Identify discrepancies, author out of specification and deviation investigations within TrackWise, and implement associated CAPAs.
Requirements
  • Education: Bachelor's Degree in Chemistry, Pharmacy, or closely related field required. Advanced degree highly beneficial.
  • Experience: 5 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience. Hands-on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.
  • Skills: Familiarity with compliance requirements within cGMP, safety, and regulatory environments. Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC, ICP, FTIR, UV-VIS equipment, and data stations required. Strong chemistry knowledge.

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