QA Document Control Specialist

Key Responsibilities:

• Manage and maintain paper-based controlled documentation systems (no electronic document management system), ensuring proper filing, storage, and accessibility of all quality records
• Own the full lifecycle of controlled documents, including creation, revision, approval, issuance, and archival
• Ensure compliance with GMP and Good Documentation Practices (GDP) across all documentation activities
• Review and format SOPs, batch records, work instructions, and validation documents for accuracy and regulatory compliance
• Issue and reconcile controlled documents, ensuring proper tracking and accountability
• Coordinate and process document change requests through established change control procedures
• Maintain document logs, trackers, and filing systems to ensure accurate recordkeeping
• Perform periodic audits of document files to ensure completeness, accuracy, and compliance
• Support internal and external audits by retrieving, organizing, and presenting documentation
• Collaborate cross-functionally with QA, Manufacturing, Engineering, and Validation teams to support documentation needs
• Train employees on document control processes, filing practices, and GDP standards
• Identify and implement process improvements to enhance document control efficiency and compliance

Qualifications:

• Bachelor’s degree preferred (Life Sciences, Quality, or related field) or equivalent experience
• 4 years of document control experience in pharmaceutical, biotech, or medical device environments
• Strong knowledge of GMP and FDA regulations
• High attention to detail and strong organizational skills
• Ability to manage multiple priorities in a fast-paced, regulated environment
• Strong communication skills and ability to work cross-functionally