San Francisco Bay Area
Quality Assurance Associate with more than 10+ years of managing and supporting document legacy structures and archival systems. Excellent proofreading, editing, and document file conversion skills. Highly proficient in managing EDMS workflows and backend troubleshooting. Organized and efficient, able to perform well under pressure. Comfortable with 21 CFR Part 11 and cGMP acumen.
Fulfill document control responsibilities which include; prepare, review, finalize, obtain approval and circulate SOPs, forms, specifications and other GXP documents within EDMS as well as physical repositories. Review and approve document change requests. Ensure compliance and completeness of proposed changes. Verify documents comply with formatting guidelines. Review referenced forms and verify associated documents are addressed. Assigns document control numbers. Maintain GXP documents posted on the company intranet. Provide user support within the EDMS. Perform other related duties and responsibilities to support Document Control and QA as defined by management.