The Document Control Specialist performs specialized document management and administrative support tasks for SOP and batch record systems as well as other tasks to assure the schedules and goals of the quality system are met.
Primary job responsibilities include:
• Perform document control functions, including document logs, tracking, processing, review, distribution, release, scanning, and archiving of documents.
• Coordinate the revision, review, and approval, retirement and issuance of SOPs and other GMP documents.
• Responsible for ensuring biennial review of all SOPs.
• Organize and ensure accurate and reliable filing systems for all paper-based GMP documents.
• Maintain training records including training matrix, training files.
• Maintain change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents.
• Actively participate in internal audits, vendor audits and other activities as assigned by manager.
• Maintain equipment records and other paper-based quality records.
• Assist in the coordination of equipment calibration.
• Quality professional with a minimum of 2-3 years of hands on experience performing document management in a regulated pharmaceutical or medical device industry with direct document control experience.
• Demonstrated knowledge of cGMPs, 21 CFR 210, 211, and 820 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
• Must be highly proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.
• Must be well-organized and proficient at reviewing and editing documentation.
• Bachelor’s degree (Preferred).