Position Title: Principal Specialist, Packaging Training
Work Location: Athens, GA 30601
Assignment Duration: 6 Months
Work Arrangement: Onsite
Position 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.
Key Responsibilities:
• 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: 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.
Qualification & Experience:
• Performs all The Organization business in accordance with all regulations (e.g., EEO, USDA, EU, EMA etc.) and The Organization 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 The Organization excellent reputation in the community
• Bachelor’s degree, from an accredited institution, in a relevant scientific discipline.
Applicant Notices & Disclaimers
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