Training Quality Assurance and Document Control Coordinator

The Training QA & Document Control Coordinator provides administrative, operational, and Quality System support to the Training Quality Assurance (QA) team, with primary responsibility for coordinating training documentation, routing training plans, monitoring training activities, maintaining training records, and supporting day-to-day Training QA operations. Working under established procedures and with guidance from Training QA Specialists and management, the coordinator helps ensure training documentation, controlled documents, and Quality System records are accurate, complete, traceable, appropriately approved, and readily retrievable.

Job Title: Training QA & Document Control Coordinator
Location - San Clemente CA
Duration – 3 Months (Possibility of extension)

Description
The Training QA & Document Control Coordinator provides administrative, operational, and Quality System support to the Training Quality Assurance (QA) team, with primary responsibility for coordinating training documentation, routing training plans, monitoring training activities, maintaining training records, and supporting day-to-day Training QA operations. The position also provides cross-functional support to Document Control and Records Management activities, including controlled document verification, DHR and batch record printing, records retention, document reconciliation, and audit/inspection readiness. Working under established procedures and with guidance from Training QA Specialists and management, the coordinator helps ensure training documentation, controlled documents, and Quality System records are accurate, complete, traceable, appropriately approved, and readily retrievable.

Requirements
Training QA Administration · Provide day-to-day administrative and operational support to the Training QA team and Training QA Specialists. · Coordinate and route training plans, assignment forms, records, assessments, and related documentation for review, approval, acknowledgment, signature, filing, or upload. · Track training requests and activities from initiation through completion; monitor open or incomplete items and follow up as needed. · Support employee training assignments and approved additions, removals, or modifications to training plans, maintaining traceable supporting documentation. · Verify completed training documentation and electronic records for administrative completeness and reconcile records during periodic training plan reviews. · Maintain Training QA logs, trackers, queues, and workload reports. · Identify documentation discrepancies or exceptions and escalate them to the appropriate Training QA Specialist or management. Training Coordination and Support · Coordinate group and instructor-led training sessions, including participant logistics, approved materials, and training records. · Monitor assigned training activities, provide routine status reports, and support compliance follow-up. · Assist employees and managers with routine questions about training processes, forms, assignments, and established workflows. · Prepare and maintain approved training materials, forms, templates, and administrative resources. · Conduct Good Documentation Practices training for new hires using approved materials and established procedures, when appropriately qualified. · Support Training QA projects, system implementations or enhancements, data cleanup, and departmental initiatives. Training System Administration Support · Perform authorized routine administration in the applicable electronic training or learning management system, including approved assignments and training-plan updates. · Support electronic routing, approvals, acknowledgments, and signatures. · Verify and reconcile system data to support accurate and complete training records. · Identify system discrepancies or processing issues and escalate them for resolution. · Assist Training QA Specialists with system reporting, testing, and improvement initiatives. Document Control and Records Management Support · Provide operational and administrative support to Document Control, including DHR and batch record printing and verification. · Support controlled document and records filing, archival, retrieval, retention, reconciliation, authorized disposition, and backlog reduction. · Verify document numbers, titles, revisions, effective dates, formatting, attachments, references, and required approvals. · Help ensure current, effective, and approved controlled documents are available for use, and obsolete or superseded versions are removed or dispositioned according to procedure. · Assist employees with routine document-control processes, templates, forms, workflows, and system questions. · Maintain document-control logs, trackers, workload reports, and applicable performance metrics. · Support Document Control projects, system enhancements, data cleanup, and activities addressing Quality System gaps identified through routine work, audits, or inspections. · Identify documentation, retention, workflow, or process issues; escalate concerns and recommend practical improvements that maintain Quality System controls. · Perform other related duties as assigned. · Support departmental metrics, reports, filing backlogs, special projects, and Quality System activities. · Identify and escalate documentation, retention, training, or process issues. · Perform other related duties as assigned.

Experience ·
2 – 4 Years of related experienced · Administrative, Quality Assurance, Quality Systems, Training, Document Control, Records Management, or related experience preferred. · Experience working in a medical device, pharmaceutical, biotechnology, life sciences, or other regulated environment preferred. · Experience with electronic document management, Quality Management, or Learning Management Systems preferred. Knowledge, Skills, and Abilities · Strong attention to detail and commitment to documentation accuracy. · Strong organizational, prioritization, and follow-through skills. · Ability to manage multiple administrative requests, workflows, and deadlines. · Ability to follow established procedures and distinguish routine administrative activities from matters requiring QA review or escalation. · Effective written and verbal communication skills. · Strong customer-service orientation and ability to work effectively with cross-functional stakeholders. · Ability to review documentation for completeness and identify inconsistencies or missing information. · Working knowledge of Good Documentation Practices and data integrity principles preferred. · General understanding of GxP-regulated Quality Systems preferred. · Proficiency with Microsoft Office applications. · Ability to learn and effectively use electronic Quality Management, Document Management, and Learning Management Systems. Physical and Work Requirements • Ability to perform computer-based work for extended periods. • Ability to organize, retrieve, and transport physical files and records. • Ability to lift and transport document boxes or binders weighing up to 25 pounds, with or without reasonable accommodation. • May require occasional schedule flexibility to support Manufacturing Operations, audits, inspections, or urgent document requests. High School Diploma or equivalent required. Associate's or Bachelor's Degree in Business Administration, Life Sciences, Quality, Regulatory Affairs, or a related discipline preferred.

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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

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