Quality Assurance Manager

5 days ago


King of Prussia, Pennsylvania, United States Beacon Hill Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Beacon Hill.

The ideal candidate will have a minimum of five years of Quality experience in the biologics or pharmaceutical industry, with excellent knowledge of CGMP guidelines, 21 CFR Parts 210 and 211 and other regulatory standards.

Key Responsibilities
  1. Leadership and Management
  • Provide oversight, leadership, and management support to QA and QC operations
Quality Control and Compliance
  • Monitor and ensure the quality of manufactured products
  • Measure, evaluate, and apply the disposition of manufactured Bulk Drug Substance and Drug Product Injection lots, including generation of Certificates of Analysis
Staff Management
  • Manage a staff of QA Specialists and QC Analysts
Process Improvement
  • Review and approval of Protocols and General Technical Reports
  • Review and approval of Disruption to Controlled Environment (DCE), including data compilation
  • Review and approval of Raw Material Specification (RMS) revisions
  • Approve Change Controls
Requirements
  1. Education
  • Minimum Bachelor of Science degree in a scientific discipline
Experience
  • Minimum five years of Quality experience in the biologics or pharmaceutical industry
Skills
  • Excellent knowledge of CGMP guidelines, 21 CFR Parts 210 and 211 and other regulatory standards
  • Writing experience in a similar role in the biologics or pharmaceutical industry
  • Experience in aseptic processing and/or mammalian cell culture production considered a plus
Preferred Qualifications
  • Positive work attitude that supports teamwork and continuous improvement
What We Offer

Beacon Hill is committed to providing a challenging and rewarding work environment for our employees. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development.

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application to join our team.



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