Training and Compliance Specialist

Duties

• Lead the Packaging (PKG) documentation team 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.
• Implements effective CAPAs to mitigate potential issues in deviations and audits.
• 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.

Qualifications

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