Quality Assurance Manager

Omaha, Nebraska Quality Engineering 111 days ago

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Summary: Seeking a Quality Assurance Manager with a strong background in pharmaceuticals to oversee and ensure compliance with Quality Policies and Standards.

Key Responsibilities:

  • Supervise Operational Quality Assurance activities for compliance with Quality Policies and Standards.

  • Provide leadership to the Quality Assurance team.

  • Draft, review, and approve Deviations, Change Controls, and Manufacturing Instructions.

  • Oversee the release of in-process and finished products.

  • Lead investigations of deviations and CAPAs, including OOS for Release/Stability and OOTs.

  • Support QC testing and sample management programs.

  • Execute quality-related processes and projects.

Qualifications:

  • Bachelor's degree in a scientific discipline required.

  • Minimum six years of experience with FDA and cGMP requirements in the pharmaceutical industry.

  • Minimum six years of experience in QA/QC practices within a pharmaceutical environment.

  • Comprehensive understanding of manufacturing within a cGMP environment, including documentation and data integrity.

Preferred Skills:

  • Direct experience with CAPA (Corrective Action/Preventive Action) processes.

  • Experience handling Deviations within pharmaceutical manufacturing.

 

 

 

 



Pay Details: $80,000.00 to $105,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
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