Document Control Specialist

Quality Assurance Document Control Specialist

This position is responsible for assisting the Sr. Manager of QA in the preparing, tracking, maintaining, copying and distribution of various quality reports, logs, records, and databases. This role manages document control and change management process and is accountable for ensuring that all controlled documents, records, and training activities meet the highest standards of accuracy, compliance, and timeliness. The role serves as a subject matter resource for the electronic Quality Management System (eQMS) and provides support, guidance, and training to cross-functional stakeholders. By ensuring strict adherence to FDA, ISO 13485, and other regulatory requirements, this position directly supports product quality, patient safety, and organizational compliance.

Key Responsibilities:

• Under the oversight of Sr QA Manager, manages document control and product change order lifecycle, including Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Quality Records, marketing collateral and other controlled documents in compliance with FDA 21 CFR Part 210, 211, 820 and other applicable regulations/standards.
• Coordinates document creation, revision, review, approval and archival workflows within the electronic Document Management System under the oversight of Sr QA Manager.
• Act as a "Super User" for the eQMS by administering access levels, approval workflows and troubleshooting system issues.
• Ensure accuracy and compliance of all submissions for completeness, reference alignment and regulatory adherence. Proactively identify process gaps and drive improvements to strengthen change management and document practices.
• Collaborate cross-functionally with managers and SMEs to help ensure controlled documents reflect current practices, training is developed for new or revised procedures and employees receive timely training aligned with job roles and responsibilities
• Prepares, tracks, maintains, copies and distributes various quality reports, logs, records, and databases under the guidance of the Sr. Manager of QA
• Tracks KPIs related to document control, training and change management. Present metrics in management reviews, highlight trends and propose corrective/preventive actions to drive efficiency and compliance.
• Monitors training completion, follow up on overdue training assignments and supports the periodic review cycle of controlled documents.
• Manages records management across all departments ensuring secure retention, archival, and destruction in alignment with records retention schedules, regulatory requirements, and legal hold notices.
• Support audits and inspections (FDA, DEA, NABP, OSHA, and customer audits) by preparing and providing accurate, timely documentation. Act as a point of contact for document-related queries during audits.
• Drive continuous improvement by participating in cross-functional initiatives, providing documentation support for process standardization, and contributing to Quality System enhancements.
• Other activities as assigned by the Manager of QA/RA.

Specific Knowledge & Skills:

• Experience in establishing and working with electronic QMS systems such as MasterControl, Agile, TrackWise etc.
• Extensive experience managing or supporting change management (and configuration control) functions.
• Demonstrated success supporting regulatory inspection and audits.
• In-depth knowledge of GMP, GDP and SOP concepts with practical application in day-to-day processes.
• Excellent verbal and written communication skills.
• Industry experience in medical devices, pharmaceuticals or biotech with a strong working knowledge ISO 13485 and FDA QSR regulations.
• Experience in working across numerous scientific and management disciplines.
• Skilled in Adobe Acrobat, Microsoft Office Suite and advanced document formatting.

General Skills & Competencies:

• Highly detail-oriented with exceptional organizational and time management skills
• Demonstrated ownership with the ability to work independently.
• Technically adept with strong computer and systems proficiency.

Minimum Work Experience:

• A minimum of 5 years of Quality Assurance, Document Control, Records Management and Archiving experience in a regulated medical device, biotech or pharmaceutical company.
• Proven track record of managing document control and change management with full accountability.

Preferred Education:

• Minimum of High School diploma or GED
• Associate degree in a business or technical or related discipline is preferred.

Travel / Physical Demands:

• Up to 10%. Normal office environment.

HealthFirst is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.