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ALKPosted 3 weeks ago

QC Manager

$110,000–$125,000 year

On-sitePlainville, Connecticut, United States

Full TimeLarge

Job Summary

Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring end-to-end compliance of incoming, in-process, and routine operations including environmental monitoring, water testing, stability, and production release. Author, edit, review, and approve documents such as SOPs, deviations, CAPAs, and change controls while managing QC administration, scheduling, and budgeting. Collaborate with departments to resolve quality matters, serve as subject matter expert during internal and external audits, and provide instructor-led training to team members on laboratory documents. Ensure calibration and maintenance of lab instrumentation, oversee product validation and stability studies, and foster a culture of quality and continuous improvement. This full-time role in Plainville, CT requires a minimum of 5 years of progressive management experience in a GMP environment with knowledge of cGMP, USP, FDA, and ICH guidelines.

Required Qualifications

  • minimum 5 years of progressive management experience in a laboratory setting with increasing responsibilities in Pharmaceutical or GMP environment
  • Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines

Desired Qualifications

  • BS / BA in life sciences, biology, chemistry or related field

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