Process Alliance · 3 days ago
Quality Assurance Specialist
Durham, NC
Full-time
Onsite
Entry, Mid Level
2+ years expProcess Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering and manufacturing services. They are seeking a Quality Assurance Specialist to support a pharmaceutical manufacturing site, focusing on managing change controls and quality documentation.
ManufacturingMedicalPharmaceuticalProduct Design
Hiring Manager
Devin Courtney
Responsibilities
Own and manage change controls end-to-end , from initiation through implementation and closure
Coordinate impact assessments across QA, Manufacturing, QC, Engineering, and other stakeholders
Drive cross-functional deliverables, implementation tracking, and on-time change control closure
Manage CAPA activities, including documentation, tracking, effectiveness checks, and closure
Support deviation investigations as needed, including documentation and follow-up actions
Ensure all quality events comply with GMP requirements and site procedures
Monitor metrics, timelines, and quality system health to support continuous improvement
Qualification
Required
Bachelor's degree in a scientific, engineering, or related field
2+ years of experience in pharmaceutical manufacturing or quality systems (GMP environment)
Demonstrated experience owning or managing change controls within a QMS
Working knowledge of CAPA management and deviation processes
Strong organizational, communication, and documentation skills
Ability to coordinate cross-functional teams and manage multiple deliverables simultaneously
Company
Process Alliance
Process Alliance provides process and instrumentation design and problem-solving solutions for pharmaceutical manufacturing.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Darren Thompson
President and CEO
Company data provided by crunchbase