Quality Assurance Specialist - Document Control

Quality Assurance Specialist - Document Control

Los Angeles | Quality Control

The QA Specialist plays a critical role in supporting quality assurance and document control activities within a 503B outsourcing facility. This position ensures that quality records, controlled documents, and QA systems are maintained in compliance with FDA 503B requirements, cGMP standards, and internal procedures. The QA Specialist will support document lifecycle management, investigations, validations, change controls, training documentation, record retention, and continuous improvement activities.

• Support the management and execution of CAPAs, deviations, investigations, and change controls.
• Assist in drafting, revising, formatting, routing, approving, issuing, and retiring SOPs, batch records, forms, specifications, protocols, reports, and other controlled documents.
• Maintain document-control workflows within the electronic quality management system.
• Verify that controlled documents are reviewed and approved by appropriate personnel before issuance.
• Assign or coordinate document numbers, revision numbers, effective dates, periodic review dates, and document classifications.
• Maintain current and obsolete versions of controlled documents and ensure only approved versions are available for use.
• Coordinate document issuance, distribution, reconciliation, retrieval, archival, and destruction activities.
• Maintain document-control logs, master document lists, revision histories, and archival records.
• Review documents for completeness, consistency, formatting, proper references, approval status, and compliance with good documentation practices.
• Support periodic review of SOPs, forms, specifications, batch records, and other controlled documents.
• Assist with the review, issuance, reconciliation, and archival of executed batch records, logbooks, controlled forms, labels, and quality records.
• Ensure superseded documents are promptly removed from points of use and appropriately archived.
• Support correction and remediation of documentation deficiencies identified during QA review.
• Assist with training-document issuance, curriculum updates, training assignments, and maintenance of training records.
• Support record-retention activities in accordance with internal procedures and applicable regulatory requirements.
• Participate in document review and approval workflows within the document-control system.

• Collaborate with cross-functional teams, including Production, QC, Engineering, and Supply Chain, to ensure required quality documentation is available, current, and completed on schedule.
• Track document-review timelines, approval status, periodic reviews, overdue records, and other document-control metrics.
• Support QA review of production records, validation documents, laboratory records, equipment documentation, and supporting quality records.
• Assist with validation documentation, including protocols, reports, and summary documents for equipment, process, cleaning, and computer systems.
• Coordinate the collection, review, and archival of supporting documentation associated with validation and qualification activities.
• Support completion and closure of quality-system records by ensuring required documentation, attachments, approvals, and references are present.

• Ensure controlled documents and QA records are complete, traceable, audit-ready, and aligned with FDA and cGMP expectations.
• Support internal audits and external regulatory inspections, including FDA, DEA, and State Board of Pharmacy inspections.
• Retrieve and organise requested documents and records during audits and inspections.
• Assist with preparation of…