Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)

The Sr. Coordinator, Controlled Documentation & Training Compliance is an experienced, independently operating contributor responsible for executing and supporting the day-to-day operations of the controlled documentation and training compliance programs within a GxP-regulated 3PL/pharmaceutical distribution environment. Reporting to the Sr. Specialist or Manager, this role carries greater technical depth, broader task ownership, and a functional oversight responsibility for the Coordinator level. The Sr. Coordinator processes and manages controlled documents and training records with a high degree of accuracy and GDP compliance, assists with eDMS and learning management system operations, contributes to audit readiness activities, and provides day-to-day guidance to the Coordinator. This role serves as a reliable operational resource for the team and is expected to work with minimal supervision on routine tasks while escalating complex issues appropriately.

KEY RESPONSIBILITIES:

• Process, format, route for approval, file, and distribute controlled documents including SOPs, work instructions, forms, and policies — in accordance with established document control procedures and cGMP/GDP requirements.

• Maintain and update document records in the eDMS with accuracy and completeness, ensuring proper version control, metadata entry, and lifecycle status tracking.

• Track document expiration dates and review cycle timelines; proactively coordinate with process owners and the Sr. Specialist or Manager to initiate timely renewals and revisions

• Maintain comprehensive physical and electronic filing systems for controlled documents and quality records in compliance with retention schedules and regulatory requirements.

• Verify that obsolete document versions are removed from active use and properly archived in accordance with document control procedures.

• Perform GDP-compliant record reviews to verify completeness and accuracy of quality records, flag discrepancies to the Sr. Specialist or Manager for resolution.

• Prepare and organize document control packages for internal audits, client audits, regulatory inspections, and document change control activities.

• Ensure confidentiality and controlled access of sensitive documentation in alignment with organizational policies and legal requirements.

• Assist with the development and maintenance of document control work instructions and SOPs as directed.

• Monitor training completion rates and identify at-risk or past-due training items; escalate proactively to the Manager prior to expiration.

• Assist in developing and updating training materials including slide decks, assessments, and Read-and-Understand documents for GxP and SOP-based training programs.

• Support new hire orientation by coordinating initial training assignments and verifying completion of required pre-task GxP, GDP, PDMA, and DSCSA training.

• Compile and organize training completion data and generate routine compliance reports for review by the Manager.

• Maintain all training records in an organized, accurate, and audit-ready state always.

• Provide guidance and troubleshooting assistance to the Coordinator on LMS/eDMS tasks and training record questions.

• Support audit and inspection preparation by retrieving training transcripts, qualification records, and document control packages; verify completeness and accuracy prior to submission.

• Assist the Sr. Specialist and/or Manager during internal audits, client audits, and regulatory inspections by serving as a knowledgeable resource on document and training records.

• Assist with tracking and follow-up on action items related to documentation or training deficiencies identified through audits, deviations, or CAPAs.

The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS:

• Education: Associate’s or bachelor’s degree in Life Sciences, Healthcare Administration, Business, or a related field; or equivalent combination of education and directly relevant experience.

• Experience: 2–4 years of experience in document control, training coordination, quality administration, or a related role within an FDA-regulated environment (pharmaceutical, biotech, medical device, or 3PL/WD preferred).

• Regulatory Knowledge: Working knowledge of cGMP, Good Documentation Practices (GDP), and foundational understanding of PDMA, DSCSA, and 21 CFR Part 11 documentation requirements.

• Systems Experience: Demonstrated experience working in an eQMS/eDMS platform and/or LMS software; experience with WMS/E