Specialist, Quality Assurance
Core
Managing Standard Operating Procedures (SOPs), Work Instructions, and Quality Management Systems (QMS) for manufacturing operations, ensuring GMP compliance and document integrity.
Role type
Quality Assurance Specialist (Document Control)
Builds
Electronic Quality Management Systems (eQMS), SOP repositories, training records, and compliance documentation.
Domain
Pharmaceutical Manufacturing / Quality Assurance
Required skills
Quality document control management, GMP compliance, Good Documentation Practices, Records retention, Electronic repository management, CAPA, Quality Management Systems (QMS), Office software proficiency (MS Word, Excel, Visio, Adobe Acrobat), Training data management
Preferred skills
Technical writing, Project management, Problem solving, Learning and Development
Responsibilities
Creating and formatting SOPs, Work Instructions, Setup Sheets, Flowcharts, and Job Aids; Managing Review and Approval Processes within eQMS; Maintaining hard copy and electronic document libraries; Cascading communications for SOP Training; Updating New & Revised SOP URLs with Effective Dates in LMS; Performing second person review of Annual Product Reports (APR); Supporting Data Integrity cross-functional projects.
Seniority
Mid-level, hands-on IC
