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/ERP systems is a plus.
KNOWLEDGE, SKILLS & ABILITIES:
Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) as applied in a regulated distribution or pharmaceutical environment.
High level of accuracy and attention to detail in document processing, data entry, and record-keeping to maintain inspection-ready quality records.
Demonstrated ability to write clear, accurate documentation entries and assist in drafting training and procedural content.
Strong organizational skills with the ability to manage multiple tasks, prioritize workload, and meet competing deadlines.
Good oral and written communication skills in English; Spanish proficiency is a plus.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); experience with eDMS platforms required.
Intermediate mathematical skills
PHYSICAL DEMANDS:
Frequently required to sit or stand for extended periods; ability to work at a computer for prolonged durations with extensive keyboard and mouse use.
Regularly required to reach, pull, stoop, bend, kneel, and/or crouch as needed within a warehouse or office setting.
Occasionally lift and/or move objects up to 35 lbs.
Expected to support audits remotely or be physically present at the facility as required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.