Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

Added
1 hour ago
Type
Full time
Salary
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Related skills

product development quality assurance gmp audit management capa

📋 Description

  • Review and approve batch records and release batches or analytical records. Write/ review/ approve
  • Lead/assist in the preparation and management of audits conducted by regulatory agencies
  • Provide quality approvals in the materials management system as defined by procedures. Write
  • Review/approve clinical documentation and specifications, as applicable.
  • Actively lead/participate on assigned project team(s) to support the product development process by
  • Generate, analyze, and report quality metrics to management. Lead/participate with support groups

🎯 Requirements

  • Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering), and/or
  • 4+ years of industry experience in Quality Assurance, production, or testing of active
  • Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical
  • Experience coordinating and planning complex activities.
  • Proven organizational skills.
  • Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.

🎁 Benefits

  • Comprehensive package of benefits including paid time off (vacation, holidays, sick)
  • Eligible to participate in short-term incentive programs.
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