Quality Assurance Specialist with Clinical and Commercial distribution operations

Employment Type: W2 Contract – 12 Months with possible extensions Pay Rate: $38.00 – $40.00/hour (determined by experience) Schedule: Monday – Thursday | 8:00 AM – 4:30 PM Remote Fridays: 8:00 AM – 4:30 PM Note: This is a W2 only role — C2C and C2H candidates will not be considered. Role Overview BEPC is seeking an experienced Quality Assurance Specialist to support Clinical and Commercial distribution quality operations in Louisville, KY. This role focuses on GMP/GDP quality oversight, regulatory compliance, transportation quality management, and distribution quality activities supporting clinical and commercial pharmaceutical products. The ideal candidate will have experience in regulated pharmaceutical, biotech, or medical device environments and possess strong knowledge of GMP/GDP operations, quality systems, and regulatory compliance processes. Key Responsibilities Manage quality activities supporting Clinical and Commercial PT distribution and in-country GMP/GDP operations Support regulatory readiness activities to ensure a compliant supply of clinical and commercial materials Artworks operations Launches Variations and renewals IMP flowcharts Manage GMP documentation and ensure compliance with IND/QIMPD requirements Provide Quality Oversight of Transportation Activities Planned events Unplanned events Product quality impact assessments Support Quality Oversight Activities Across Transport providers Warehousing and distribution centers External partners Contract manufacturing organizations (CMOs) In-country testing laboratories Customer complaint intake Complaint investigations and responses Deployment of customer-focused quality solutions Build and support Quality capabilities within Distribution Quality and Country Quality Network operations Identify and Drive Continuous Improvement Initiatives Based On Customer needs Regulatory requirements Industry trends Operational performance metrics Ensure audit and inspection readiness for GMP/GDP distribution operations Support implementation of Quality requirements within the Pharmaceutical Quality System (PQS) Release, Reject, or Quarantine Clinical materials IMP products Commercial medicinal products Support product disposition activities in compliance with cGMP and internal quality standards Qualifications Life Sciences, Quality, Related scientific discipline preferred Experience In Pharmaceutical quality assurance GMP/GDP operations Regulated environments Strong Knowledge Of cGMP GDP requirements Regulatory compliance Pharmaceutical quality systems Experience Supporting Audits Inspections Quality documentation Strong analytical, organizational, and communication skills Ability to work independently and collaboratively in cross-functional teams Strong attention to detail and problem‑solving abilities Preferred Qualifications Experience With Clinical supply distribution Commercial pharmaceutical distribution Transportation quality oversight Familiarity With Swissmedic requirements IND/QIMPD documentation IMP operations Experience supporting continuous improvement initiatives and quality metrics Cross‑functional pharmaceutical quality environment Fast‑paced regulatory and distribution operations setting Education Bachelor's (Required) Experience Pharmaceutical quality assurance: 3 years (Required) GMP/GDP operations & Distribution Quality: 3 years (Required) Audits, Inspections & Quality documentation: 3 years (Required) #J-18808-Ljbffr BEPC Inc. - Business Excellence Professional Consulting