Quality Assurance Specialist

3 weeks ago


Indianapolis, Indiana, United States BioSpace, Inc. Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist - Materials Management to join our team at BioSpace, Inc. This role will be responsible for providing quality oversight for the suppliers and materials utilized by our Parenteral Products site.

Key Responsibilities

  • Coordinate the Approved Supplier List, including additions, deletions, and modifications to existing materials and suppliers.
  • Conduct material and supplier risk assessments and periodic reviews of supplier performance.
  • Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements.
  • Maintain complaint database and track supplier responses for warehouse, incoming, and operations complaints.
  • Provide quality support to the Parenteral Supplier Committee and regulatory inspection activities as needed.
  • Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.

Requirements

  • Demonstrated relevant experience in a GMP facility.
  • Proficiency with current computer systems and applications, including Microsoft Office products, LMS, EDMS, and TrackWise or similar systems.
  • Experience in material management, quality systems, and cGMPs.
  • Bachelor's Degree or equivalent experience in a science-related field.

About Us

BioSpace, Inc. is a global healthcare leader committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs.



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