MQA Specialist I

About the role

This position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. The role recommends corrective action in response to deviations noted, ensures compliance with SOPs and cGMPs, and maintains finished product reserve sampling and FDA retention sample storage areas.

Responsibilities

• Drive a culture of continuous quality improvement through on-the-shop-floor presence.
• Act with competency and integrity as Quality Assurance personnel, ensuring adherence to required processes.
• Authorized to stop production activities and contain materials/products where Critical Deviations are noted.
• Escalate isolated and systemic issues to site management, including proposed CAPAs.
• Perform MQA shop-floor activities covering production and support processes, including but not limited to:
  • Weighing and Dispensing verification
  • Bulk Solution Preparation
  • Component Preparation identification and verification
  • Monitoring of In-Process Controls
  • Oversight of Filling/Lyophilization activities (including Aseptic Gowning Qualification)
  • Finishing Activities (e.g., Integrity Testing Verification, inspection requirements/timelines, sampling plan execution)
  • Performance of Visual Inspection (AQL)
  • Packaging oversight
  • Warehousing/Storage requirement adherence
  • Monitoring of Facilities and Utilities per required parameters
• Serve as the QA key contact to shop floor employees for issue escalation and real-time documentation/troubleshooting.
• Participate in 5S activities.
• Support investigations and root-cause analyses (incidents and investigations).
• Review shop-floor documentation of MBRs and logbooks for GMP and procedural compliance.
• Support quality, compliance, and continuous improvement projects.
• Perform special oversight activities as needed, including:
  • Media fills
  • Repackaging
  • Reworking
  • Validation/investigation study activities
• Other duties as assigned.

Pay

Salary range: $60,966–$85,694. Final pay determinations will depend on factors such as experience level, education, knowledge, skills, and abilities.

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Disability insurance
• 401K with company contribution
• Wellness program