QA/ Documentation Specialist
Job Summary
The Principal Specialist, Packaging Training & Compliance will lead the Packaging (PKG) documentation team in order to support the production line as required through batch documentation review, deviations, change controls, CAPAs, and document creation/revision in compliance with procedures and regulatory requirements.
Develops, reviews, and maintains an up-to-date training program to meet all compliance requirements and packaging requirements. Maintains supplemental training records and ensures all personnel are up to date on all compliance requirements. Primary means of tracking training will be through LOS System. On the Job Training (OJT) will tracked separately outside of LOS.
Implements effective CAPAs to mitigate potential issues in deviations and audits. Product Release: Oversees the review/approval of manufacturing records, deviations, product holds / dispositions, change controls, CAPAs, document creation/revision, etc. as needed to release product according to applicable procedures. Acts as PKG internal SME for routine production issues leading towards deviations, product dispositions, and response corrections needed to continue production.
Supervisor Areas
Lead PKG document specialist through daily operations. Conduct or assist with performance evaluations and development discussions.
Skills
Performs all company business in accordance with all regulations (e.g., EEO, USDA, EU, EMA etc.) and company policies and procedures. When violations are noted/observed, they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain ****’s excellent reputation in the community.
Requirements
- Bachelor’s degree from an accredited institution in a relevant scientific discipline.
Benefits
- Health Insurance: Medical, dental, and vision coverage
- Retail Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.