Senior Quality Assurance Specialist
Cornerstone
Fort Worth, TX
Senior Quality Assurance Specialist – Operations
Fort Worth
TX
76177
CornerStone Professional Placement is seeking a Senior Quality Assurance Specialist – Operations for a pharmaceutical / regulated manufacturing client in the Fort Worth / Dallas, TX area. As the Senior QA Specialist, you will be responsible for leading TrackWise investigations, deviations, and CAPAs, providing QA oversight for distribution and operations, and serving as the quality point of contact for CMOs and logistics partners. Qualified candidates will have 5–7+ years of Quality Assurance experience in a regulated environment with strong hands-on ownership of investigations. This is an exciting opportunity to join a highly regulated organization with competitive hourly pay, strong operational exposure, and long-term project stability.
Responsibilities for the Senior Quality Assurance Specialist – Operations
- Serve as the primary TrackWise SME for operations-related investigations, deviations, complaints, and CAPAs
- Lead end-to-end quality investigations, including root cause analysis and compliant documentation closure
- Act as the QA point of contact for distribution complaints involving CMOs and logistics service providers
- Perform quality release activities for finished product distribution, including visual inspection for the US market
- Oversee temperature monitoring programs for distribution centers, cold storage, and product shipments
- Review and approve artwork, labeling, and rework instructions to ensure cGMP compliance
- Support new product introductions and product changes from a Quality Systems perspective
- Participate in regulatory inspections, audit readiness, and remediation activities
- Drive or support continuous improvement initiatives (Lean / Six Sigma projects)
Requirements for the Senior Quality Assurance Specialist – Operations
- Bachelor’s degree required
- 5–7+ years of Quality Assurance experience in a regulated environment (pharmaceutical, biotech, medical device, or similar)
- Strong working knowledge of cGMP / GxP regulations
- Experience supporting distribution, warehouse, logistics, or supply chain quality activities
- Proven ability to work independently and manage multiple quality events simultaneously
- Strong written documentation, organizational, and communication skills
- Lean / Six Sigma Yellow Belt or higher preferred
Compensation for the Senior Quality Assurance Specialist – Operations
- Employment Type: 6 months of contract potential to hire
- Schedule: Monday–Friday 40 hrs. a week
- Pay Rate: Based on Experience (Open for candidates pay)
- Location: On-site (Fort Worth, TX 76177)
- Benefits: Medical, dental, vision (per contract eligibility)
To apply for this job, please email resumes to:
ezekielp@cornerstonestaffing.com