QA Document Control Associate

The Temporary QA Document Control Associate supports the Quality Assurance (QA) department by assisting with the digitization, organization, and verification of GMP documentation. This position is responsible for scanning controlled documents and ensuring that electronic records are complete, legible, and are an accurate representation of the original paper records. The ideal candidate is detail-oriented, organized, and able to follow established procedures while maintaining data integrity and document accuracy.

Principal Accountabilities

• Ensure compliance with all relevant laws and regulations as well as company procedures, policies, and SOPs.
• Scan GMP documentation using approved/appropriate document scanning procedures.
• Verify that scanned electronic documents are complete, legible, and accurately represent the original paper documents and compliant with company procedures.
• Perform page-by-page quality checks to confirm all pages have been captured in the correct order and orientation.
• Identify and resolve issues such as missing pages, poor image quality, duplicate pages, or incomplete scans.
• Organize and index scanned documents according to established document control procedures.
• Upload and verify scanned documents into the approved electronic document management system.
• Maintain accurate tracking logs and records of scanned documents.
• Handle controlled documents in accordance with GMP, Good Documentation Practices (GDP), ALCOA+ and company procedures.
• Support document archival, retrieval, filing, and record management activities.
• Communicate discrepancies or documentation issues to QA personnel for resolution.
• Maintain confidentiality of quality records and proprietary information.
• Assist with other QA and Document Control activities as assigned.

Special Factors

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, scanners, and filing cabinets. Occasional walking, reaching, handling, twisting, and bending spine at waist when filing or operating office equipment. The role involves sitting at a computer and using a computer keyboard for long periods of time.

Person Specification

• Attention to detail
• Accuracy and quality focus
• Strong organizational skills

Qualifications / Knowledge / Experience

• High school diploma or equivalent is required.
• Prior experience in a regulated industry is required.
• Minimal experience in QA/Document Control Role in GMP industry is preferred.
• Basic knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ALCOA+ and Quality Assurance principles.
• Proficiency in Microsoft Word, Excel, Outlook, Adobe Pro.
• Ability to learn electronic document management systems.
• Ability to exercise sound discretionary judgment, prioritize multiple competing tasks, and work with some supervision.
• Strong organizational and time management skills.
• Incumbent must be able to sit at a computer and to use a computer keyboard for long periods of time.

Experience Level

This is a fairly junior temporary position and training will be provided. Candidates with QA, Document Control, regulated industry or general administration experience are welcome to apply.