QA Specialist IV-Operations
Core
Reviewing and approving GMP documentation and validation records to ensure compliance with cGMP regulations in a pharmaceutical manufacturing environment.
Role type
Senior QA Specialist (Operations)
Builds
Compliant GMP documentation and validation packages for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP documentation review, validation protocol review, regulatory compliance knowledge, technical writing, analytical skills, revision control management
Preferred skills
Cross-functional collaboration, continuous improvement, independent work
Technologies
Document management systems, electronic batch records
Responsibilities
Independently review and approve GMP documentation including SOPs and work instructions, Review and approve validation and qualification documentation for equipment and computer systems, Provide detailed feedback and recommendations during document review, Ensure document changes are justified and aligned with revision control processes, Serve as a subject matter resource for document review related to validation and analytical systems, Collaborate with cross-functional teams to resolve documentation and quality issues
Seniority
Senior, hands-on IC
