Quality Assurance Specialist - Document 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.

Job Activities and Responsibilities: Quality Systems & Documentation

• 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• Ensure superseded documents are promptly removed from points of use and appropriately archived.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.

Quality Operations Support

• 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.

Compliance & Inspection Readiness

• 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 organize requested documents and records during audits and inspections.
• Assist with preparation of document indexes, inspection-request logs, evidence packages, and supporting records.
• Participate in mock audits and inspection-preparation activities.
• Support periodic review of document-control practices to ensure continued compliance with internal procedures and regulatory expectations.
• Identify missing, overdue, incomplete, or obsolete documents and coordinate correction with the responsible department.

Continuous Improvement

• Identify and propose improvements to document-control processes, document templates, review workflows, record-retention practices, and quality systems.
• Support implementation of QA process enhancements aligned with operational goals and compliance standards.
• Assist with standardization of document formats, naming conventions, templates, and approval workflows.
• Support development and monitoring of document-control and quality-system metrics.
• Participate in remediation activities related to documentation errors, overdue reviews, training gaps, and record-management deficiencies.

Required Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• 2–4 years of experience in Quality Assurance or document control in a pharmaceutical or 503B manufacturing environment.
• Working knowledge of cGMP, FDA 503B guidance, USP <797>, <800>, and <85> requirements.
• Strong written and verbal communication skills, with excellent attention to detail.
• Proficient with document-control systems and tracking tools, such as Qualio, MasterControl, MS Project, and Excel.

Preferred Qualifications

• Experience in sterile compounding, aseptic manufacturing, or regulated drug production.
• Knowledge of validation lifecycle and quality risk-management principles.
• Familiarity with electronic quality management systems and controlled-documentation practices.
• Experience with controlled-document issuance, revision, archival, periodic review, and record retention.

Other Responsibilities

• Collaborate with different teams to coordinate documentation timelines necessary to meet the production schedule.
• Support cGMP production-facility activities.

Physical Requirements

• Good hand-eye coordination.
• Ability to repeatedly sit and stand for periods of time.
• Ability to lift up to 30 lbs.

Reports to

the QA Manager or as assigned.

Appearance

Must wear clean scrubs when in the facility.