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Senior Quality Associate

2 months ago

Novato, California, United States BioSpace, Inc. Full time
Job Summary

BioSpace, Inc. is seeking a highly skilled Senior Quality Associate to join our team in the Technical Operations group. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities:
  • Provide on-the-floor quality assurance oversight and support to manufacturing operations
  • Review executed batch records and associated documentation to ensure compliance with approved procedures and regulatory expectations
  • Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
  • Represent quality assurance in support of deviations, including active participation in Root Cause Analysis (RCA)
  • Provide regulatory compliance guidance to manufacturing and manufacturing sciences and technology (MSAT) personnel
  • Provide quality assurance support, including writing, reviewing, and approving documents in quality management systems in accordance with BioSpace, Inc. policies
  • Perform area walkthroughs
  • Perform other duties and projects as assigned by management
Requirements:
  • BS/BA in a scientific discipline or related field and 6-8 years of experience in a biologics manufacturing environment
  • Prior batch record review experience is required
  • Prior experience in investigation, change control, and other quality management systems (QMS)
  • Working knowledge of regulatory compliance and quality management systems
  • Excellent written and verbal communication and interpersonal skills
  • Must display strong analytical and problem-solving skills
  • Manufacturing and MSAT experience preferred
What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • A dynamic and collaborative work environment
  • Shift differential pay for off-hour shifts