Quality Assurance Document Control Assistant

Summary

The Quality Assurance Assistant – Document Control supports the Quality Assurance department by assisting with the issuance, routing, tracking, reconciliation, archival, and maintenance of controlled documents and quality records within a regulated pharmaceutical environment. This role supports compliance with cGMP, Good Documentation Practices (GDP), FDA regulations, and company procedures by ensuring documents are accurate, complete, current, properly controlled, and readily retrievable for routine operations, audits, and regulatory inspections.

The position requires strong attention to detail, organization, confidentiality, and the ability to work cross-functionally with document owners and Quality personnel.

6 month contract position.

• High school diploma or equivalent required;
  Associate Degree preferred.
• Minimum of 1-3 years of experience in Quality Assurance, Document Control, records management, or a regulated pharmaceutical, medical device, or GMP environment preferred.
• Working knowledge of cGMP, Good Documentation Practices (GDP), document control principles, and controlled document life cycle activities preferred.
• Strong attention to detail with the ability to verify document accuracy, completeness, effective dates, revision status, and required approvals.
• Excellent organizational skills with the ability to maintain accurate logs, files, records, and document tracking tools.
• Proficient in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint; experience with electronic document management or quality systems preferred.
• Ability to read, understand, and follow SOPs, work instructions, forms, and applicable quality system requirements.
• Strong written and verbal communication skills with the ability to interact professionally with cross-functional personnel.
• Ability to work independently and as part of a team while managing multiple priorities and meeting established deadlines.
• Demonstrated ability to maintain confidentiality and handle controlled records in an accurate and compliant manner.

• Support the issuance, distribution, retrieval, reconciliation, and archival of controlled documents, including SOPs, work instructions, forms, batch records, protocols, reports, and related Quality documents.
• Assist with maintaining document control logs, document trackers, effective date records, training copies, archival files, and controlled copy inventories in an accurate and inspection-ready condition.
• Route documents for review and approval in accordance with approved procedures and follow up with document owners, reviewers, and approvers to support timely completion.
• Verify that controlled documents contain the appropriate document number, title, revision level, effective date, approval signatures, formatting, and required attachments prior to issuance or filing.
• Support document change activities by assisting with document preparation, formatting, redlines, change request packages, and record organization as directed by Quality Assurance management.
• Maintain current and obsolete document files to ensure superseded documents are removed from use, properly marked, archived, and retained in accordance with company procedures and record retention requirements.
• Assist with scanning, indexing, filing, and retrieval of quality records to support audits, inspections, investigations, batch record review, training verification, and routine Quality Assurance activities.
• Support periodic document review activities by identifying documents due for review, notifying owners, tracking status, and escalating overdue items as needed.
• Assist with preparation and organization of documentation requested during internal audits, customer audits, and regulatory inspections while maintaining good documentation practices and data integrity expectations.
• Perform all other tasks or projects assigned by the QA Manager or the Senior Quality Manager.

• Comply with all company safety policies, procedures, and applicable OSHA requirements.
• Perform primarily administrative and document handling activities in an office and controlled records environment.
• Regularly use hands and fingers for typing, filing, scanning, copying, organizing records, and general computer work.
• Ability to sit for extended periods, with occasional standing, walking, bending, reaching, or lifting associated with document filing and record retrieval.
• Ability to…