Documentation Coordinator Technician

Responsibilities:

• The 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: Oversee 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
• .Act 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
• .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 Company AH excellent reputation in the community

Experience:

• Bachelor’s degree, from an accredited institution, in a relevant scientific discipline.