Principal Specialist (Packaging Training & Compliance)

Cynet Systems•Athens, GA

About The Position

This role is responsible for leading the Packaging (PKG) documentation team to support the production line. The Specialist will ensure compliance with procedures and regulatory requirements, develop and maintain training programs, and oversee the review and approval of various manufacturing documents. This position also acts as an internal Subject Matter Expert (SME) for production issues and leads the PKG document specialist team.

Requirements

Demonstrated high ethical and professional standards with all business contacts.
GMP.
Batch documentation review.
Deviations.
Change controls.
CAPAs.
Document creation and revision.
Training program development.
LOS System.
On the Job Training (OJT).
Product Release oversight.
Subject Matter Expertise (SME) in production issues.
Team leadership and supervision.

Responsibilities

Lead the Packaging (PKG) documentation team to support the production line through batch documentation review, deviations, change controls, CAPAs, and document creation/revision.
Ensure compliance with procedures and regulatory requirements.
Develop, review, and maintain an up-to-date training program to meet all compliance and packaging requirements.
Maintain supplemental training records and ensure all personnel are up to date on all compliance requirements.
Track training through LOS System and manage On the Job Training (OJT) records separately.
Implement effective CAPAs to mitigate potential issues in deviations and audits.
Oversee the review and approval of manufacturing records, deviations, product holds/dispositions, change controls, CAPAs, and document creation/revision to release product.
Act as PKG internal SME for routine production issues leading towards deviations, product dispositions, and response corrections.
Lead PKG document specialist through daily operations.
Conduct or assist with performance evaluations and development discussions.
Perform all business in accordance with all regulations (e.g., EEO, USDA, EU, EMA etc.) and organizational policies and procedures.
Report any noted or observed violations immediately to management.