Overview
Quality Assurance Specialist I Jobs in Louisville, KY at BEPC Inc. – Business Excellence Professional Consulting
Title: Quality Assurance Specialist I
Company: BEPC Inc. – Business Excellence Professional Consulting
Location: Louisville, KY
Job Title: Quality Assurance Specialist
Location: Louisville, KY 40258 (Hybrid)
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
Benefits: Medical, Dental, Vision, and Life Insurance
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 compliant supply of clinical and commercial materials
Provide quality oversight for:
- Artworks operations
- Launches
- Variations and renewals
- IMP flowcharts
- Manage GMP documentation and ensure compliance with IND/QIMPD requirements
Provide quality oversight of transportation activities including:
- 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
Support customer engagement activities including:
- 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
- Medical devices
- Support product disposition activities in compliance with cGMP and internal quality standards
Qualifications:
- Bachelor’s degree in:
- Life Sciences
- Quality
- Engineering
- Related scientific discipline preferred
Experience in:
- Pharmaceutical quality assurance
- GMP/GDP operations
- Distribution quality
- Regulated environments
Strong knowledge of:
- cGMP
- GDP requirements
- Regulatory compliance
- Pharmaceutical quality systems
Experience supporting:
- Audits
- Inspections
- Quality documentation
- Product disposition activities
- 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
- Complaint handling processes
- Familiarity with:
- Swissmedic requirements
- IND/QIMPD documentation
- IMP operations
- Experience supporting continuous improvement initiatives and quality metrics
Work Environment:
- Hybrid schedule: Onsite Monday–Thursday
- Remote Fridays
- Cross-functional pharmaceutical quality environment
- Fast-paced regulatory and distribution operations setting
- Multiple interview rounds required
About BEPC:
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
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