Document Control & Training Specialist

Mission Statement: Our mission is the development and manufacturing of products that improve the lives of animals, while ensuring the safety, quality, and compliance of the products to the highest industry standards.

JOB TITLE: Document Control & Training Specialist

DEPARTMENT: Quality Assurance

REPORTS TO: Director of the Quality Unit

EXEMPT/NON-EXEMPT: Non-exempt

EMPLOYMENT TYPE: Full Time

The Document Control & Training Specialist is responsible for the administration, control, and continuous oversight of Vetio’s electronic Quality Management System (eQMS) and site training program.

This role manages the lifecycle of controlled documents and quality records while ensuring compliance with applicable regulatory requirements including 21 CFR Parts 210/211, 21 CFR Part 507, NASC standards, and Vetio internal procedures.

The position requires strong experience with electronic quality management systems and ownership of workflow execution, including routing records, tracking status, and proactively following up with stakeholders to ensure timely completion of quality system processes.

The role also administers the employee training system, including onboarding and offboarding training assignments, job-based curriculum management, training delivery, and maintenance of compliant training records.

Document Control & eQMS Administration

· Maintain control of all quality system documents—SOPs, Work Instructions, Forms, Specifications, Batch Records, and Logs—throughout their lifecycle using the electronic QMS (eQMS).

· Administer and manage document workflows within the electronic Quality Management System (eQMS), including routing records for review and approval, tracking status, and proactively following up with stakeholders to ensure timely completion.

· Verify adherence to Vetio document formatting, numbering, and revision control requirements.

· Monitor effective dates for approved documents and coordinate controlled distribution across departments.

· Monitor eQMS workflow dashboards to identify overdue tasks and escalate stalled records to management when required.

Training Program Administration

· Ensure the training program complies with personnel qualification and training requirements under 21 CFR 211.25 and applicable quality standards.

· Administer and maintain the employee training program within the electronic QMS.

· Assign training curricula based on employee job functions and regulatory requirements.

· Manage training assignments associated with new or revised controlled documents.

· Coordinate onboarding training for new hires including GMP, GDP, data integrity, safety, and role-specific SOP training.

· Manage training reassignment during employee transfers, role changes, or departmental movement.

· Manage offboarding training updates and ensure accurate closure of employee training records upon separation.

· Monitor training completion metrics and follow up with departments to ensure timely completion.

· Deliver instructor-led training sessions as required (GMP fundamentals, documentation practices, QMS procedures, etc.).

· Maintain training matrices aligned with job descriptions and regulatory requirements.

Controlled Logbook, Notebooks & Record Management

· Issue, track, and reconcile controlled logbooks for laboratory notebooks, production, packaging, cleaning, calibration, and in-process testing activities, ensuring documentation aligns with requirements for process control and time limits.

· Maintain logbook issuance and reconciliation registers, ensuring traceability and accountability for all controlled records.

· Review completed logs for accuracy and completeness prior to archival, ensuring that in-process data are properly captured and closed per established timelines.

· Manage issuance and retrieval of batch production and packaging records, ensuring complete documentation prior to QA release.

Scanning, Filing & Archival

· Oversee the scanning, verification, and filing of executed records (batch records, logbooks, equipment logs, and other controlled documents).

· Ensure scanned files are legible, complete, and correctly indexed in the eQMS or digital archive, consistent with ALCOA+ data integrity principles and internal quality policies.

· File original hard copies securely and maintain organized archives to ensure document traceability and rapid retrieval for audits or investigations.

· Manage archival of obsolete documents and ensure proper version control to prevent unintended use.

· Coordinate proper reconciliation and transport of documents to external archival.

Quality Systems Oversight & Compliance Support

· Monitor document control and training system performance metrics to identify compliance risks and recommend corrective or preventive actions when needed.

· Collaborate with QA, QC, Production, R&D, and Technical Services to ensure timely issuance, retrieval, and control of required documentation supporting manufacturing, testing, and process monitoring activities.

· Ensure new or revised controlled documents are properly linked to required employee training assignments within the eQMS.

· Maintain audit-ready document control areas, ensuring quick retrieval and traceability of records for internal, client, and regulatory inspections.

· Support inspection readiness by maintaining compliant documentation and complete metadata within the eQMS.

· Participate in document control system enhancements, validation activities, and process improvement initiatives.

· Identify opportunities to streamline issuance, scanning, and archival workflows to enhance compliance and efficiency.

· Performs other related duties as assigned by management.

• Bachelor's Degree (BA) from four-year college or university in Life Sciences, Quality, or related discipline preferred.

• Minimum 3–5 years of experience in Document Control, Quality Systems, or Training administration within a regulated manufacturing environment (pharmaceutical, veterinary, medical device, dietary supplement, or food).

• Extensive hands-on experience administering, managing, or configuring workflows within an electronic Quality Management System (eQMS) is required.

• Experience with Salesforce-based quality systems or similar configurable workflow platforms is strongly preferred.

• Certificates, licenses and registrations required: 

o N/A

• Computer skills required:

o Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

o Microsoft Teams

o SharePoint

o ERP Systems (SAP)

o Quality Management Systems (QMS)

• Other skills required :

o GMP Documentation and Compliance

o Understanding of standard operating procedures (SOPs) and work instructions

o Strong organizational and follow-up skills.

o Proficiency in Microsoft Office Suite.

o Excellent attention to detail and communication skills.

o Ability to manage multiple workflows simultaneously.

o Training program administration and curriculum management

o Knowledge of personnel training requirements under 21 CFR 211.25

o Experience delivering instructor-led training

o eQMS workflow tracking and system administration