Quality Assurance Supervisor

2 days ago


Baltimore, Maryland, United States Medvacon Life Sciences Full time
Job Title: Supervisor, QA OTF Support

This position requires a strong commitment to quality and compliance, with a focus on ensuring the safety of patients, consumers, and employees. The role involves providing oversight of the QA on the Floor program and supervision of OFT processes and personnel.

Key Responsibilities:
  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation
  • Build effective teams that apply their diverse skills and perspectives to achieve common goals
  • Oversee daily activity for the group to ensure quality results
  • Performance management for direct reports
  • Drive and own the Quality on the Floor program by facilitating the desired 'way of working' and a quality culture
Requirements:
  • Masters' degree in a Scientific, Engineering, or Biotech field with 4+ years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry
  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs
  • Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish
  • Familiarity with electronic systems, including developing and producing reports using Microsoft products
What We Offer:
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package


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