Description
We are looking for a Quality Systems Document Control Specialist to join our Quality Unit in New Albany.
The successful candidate will support the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations.
Responsibilities include:
- Supporting the administration of the Document Control System
- Implementing change controls and assessing their impact on site documentation and processes
- Designing and enhancing quality system tools and workflows
- Issuing and tracking SOPs and other controlled documents
- Drafting, editing, and formatting SOPs, work instructions, and policies
- Managing SOP lifecycles, including periodic review and approval workflows
- Supporting cross-functional SME reviews of SOPs and controlled documents
- Ensuring timely training roll-out for new or revised SOPs
- Maintaining electronic and physical filing systems
- Monitoring document-related deviations and escalating to QA Management
- Preparing documentation packages for regulatory inspections and customer audits
- Collaborating with QS Management to improve the document control process
Requirements:
- Bachelor's degree in a relevant discipline (science, quality, or engineering-related field)
- 3+ years of experience in quality, manufacturing, or a regulated industry
- Hands-on experience with SOP drafting, formatting, and controlled documentation systems
- In-depth knowledge of cGMP documentation practices, USP standards, and FDA record-keeping requirements
- Exceptional attention to detail with strong editing, writing, and organizational skills
- Familiarity with electronic document management systems (EDMS) or validated document control or quality management software