The Quality Assurance Document Control Specialist will be responsible for creating, distributing, and maintaining all documentation necessary to control manufacturing processes and ensure conformance to regulations. The position will maintain the process for Batch Production Records, Master Manufacturing Records, records management, document control, and change control using a paper-based system. As part of the Quality organization, this role will participate in continuous process-improvement initiatives.
- Generate and review Batch Production Records and all corresponding documentation before issuing to Production.
- Create, update, and maintain Master Manufacturing Records.
- Assign and maintain system for Batch, Lot, and Purchase Order identifiers.
- Generate Purchase Orders to Warehouse for raw and packaging materials required for Production.
- Receive, support, and respond to Document Revision Requests. Review and implement submitted changes to controlled procedures, forms, specifications, Lab Testing Records, and other critical documents in accordance with established priorities.
- Maintain Document Revision Request log and regularly communicate with impacted functions on status of requests.
- Accurately file and maintain the latest physical and electronic copies of all company documentation in accordance with regulations.
- Maintain employee training records for all functions using a paper-based filing system.
- Interface with cross functional team members to resolve quality discrepancies and ensure prompt delivery of folders to Production.
- Review Certificate of Analysis in accordance with Quality Control Lab Testing Reports
- Receive, review, and respond to Customer Complaints in collaboration with Quality Control function.
- Review and approve the quality, printing, and art work of finished product labels
- Perform other duties as needed.
- Bachelor’s Degree in Scientific, Business, or related field, or a combined 3-5 years of experience working within a regulated Manufacturing environment in a similar role (Document Control, Configuration Management, Quality Control, Quality Systems, etc.).
- Must possess an understanding of cGMP standards, 21 CFR Part 111 or related regulations, and the relation of these regulations to documentation.
- Computer Skills: Proficiency in Microsoft Excel (formulas, pivot tables, etc.), Microsoft Word, and Outlook. Experience and/or familiarity with different types of Manufacturing software (ERP, PLM, PDM, eQMS) is a plus.
- Must possess an understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP) regulations.
- Superb written and verbal communication skills. Must be able to interact and build relationships with various functions.
- Extremely good observation skills and a high attention to detail.
- Ability to independently organize workload to meet deadlines while working under pressure in a fast paced environment.
- Strong time management, organization, prioritization, and problem solving abilities.
- Ability to identify and proactively resolve quality discrepancies.