Quality Assurance Documentation Specialist

Job Description

Salary:

Job Summary

We are seeking a highly organized and detail-driven Quality Assurance Documentation Specialist to support GMP compliance and maintain rigorous URAC accreditation, Board of Pharmacy compliance, and GMP-aligned operations within a pharmaceutical distribution environment.

This individual will be critical in managing the lifecycle of quality system documentation, ensuring inspection readiness, driving effective change management, and upholding a culture of continuous quality improvement.Key ResponsibilitiesDocumentation Control and Management

Manage the complete lifecycle of GMP documents including SOPs, forms, specifications, protocols, reports, and quality agreements.

Ensure documents are written, reviewed, and approved in accordance with cGMP, FDA, URAC, Board of Pharmacy, and internal quality standards.

Maintain and update the Document Management System (DMS) with stringent version control, access permissions, and timely distribution of controlled documents.

Issue, reconcile, archive, and retrieve documentation to support internal audits, regulatory inspections, and operational needs.

Conduct internal audits of document control processes to ensure compliance with Good Documentation Practices (GDocP) and Data Integrity (ALCOA+) principles.

Compliance and Change Management

Support inspection readiness activities by ensuring documentation is always audit-ready and aligns with regulatory and accreditation standards.

Collaborate with cross-functional teams to support timely document updates and controlled change management processes.

Manage document change control workflows, tracking change requests, coordinating reviews, and facilitating approvals.

Assist in the development and revision of documentation-related SOPs and process workflows, embedding continuous improvement principles.

Support and monitor adherence to GMP standards across all quality and operational documentation processes.

Training and Quality Systems Support

Provide document control support for onboarding of new employees and ongoing training administration for GMP documentation.

Ensure all staff have access to current, accurate, and approved documents as part of compliance and operational excellence efforts.

Partner with Training, Operations, and Quality teams to integrate document changes into the training matrix.

QualificationsRequired:

Bachelors Degree in Pharmacy, Life Sciences, Chemistry, Healthcare Administration, or a related field.

Minimum of 5+ years of experience in a regulated pharmaceutical, healthcare, or life sciences environment, with direct involvement in document control or quality systems.

Strong working knowledge of GMP guidelines, URAC standards, and Board of Pharmacy regulations.

Proficiency in Good Documentation Practices (GDocP) and Data Integrity (ALCOA+) standards.

Experience managing electronic document management systems (EDMS/DMS).

Strong organizational, analytical, interpersonal, and written communication skills.

Experience supporting regulatory inspections and audits.

Preferred:

Experience with batch record review and approval.

Familiarity with audit trail reviews and data integrity inspections.

Background working in pharmaceutical manufacturing, pharmacy operations, or quality control settings.

Ability to thrive in a fast-paced, highly regulated environment with strict operational deadlines.

Core Competencies

Quality-first mindset and attention to detail.

Skilled in proactive change management and continuous improvement methodologies.

Ability to work independently and collaboratively across departments.

Strong sense of urgency and commitment to compliance excellence.

Adaptable and able to manage multiple priorities efficiently.

Full-time