Quality Assurance Document Control Assistant

JOB QUALIFICATIONS:

•  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.

POSITION RESPONSIBILITIES:

• 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• Maintain current and obsolete document files to ensure superseded documents are removed from use, properly marked, archived, and retained in accordance with company procedures and record retention requirements.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.

PHYSICAL REQUIREMENTS:

• 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 occasionally lift and/or move document boxes or records up to 25 lbs.
• Wear required personal protective equipment (PPE) when entering GMP, warehouse, production, or laboratory areas, as applicable