Principal Specialist, Packaging Training

Spectraforce Technologies; Athens (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Spectraforce Technologies is seeking a Principal Specialist, Packaging Training to lead the packaging documentation team onsite in Athens, GA. The role focuses on ensuring regulatory compliance, conducting batch documentation reviews, managing deviations and CAPAs, and maintaining the training program for packaging requirements.

The successful candidate will drive continuous improvement in documentation quality, support product release activities, and mentor staff while coordinating with

Qualifications

• Lead PKG documentation team to support production via batch documentation review, deviations, change controls, CAPAs, and document creation/revision per procedures and regulatory requirements.
• Develop, review, and maintain a compliant training program for packaging requirements.

Responsibilities

• Lead PKG documentation team to support production through batch documentation review, deviations, change controls, CAPAs, and document creation/revision in compliance with procedures and regulatory requirements.
• Develop, review, and maintain an up-to-date training program to meet all compliance requirements and packaging requirements.
• Maintain supplemental training records and ensure personnel are up to date on compliance requirements (LOS tracking).
• On the Job Training (OJT) tracked separately outside LOS.
• Implement effective CAPAs to mitigate issues in deviations and audits.
• Product Release: review/approve manufacturing records, deviations, holds, dispositions, change controls, CAPAs, and documents for product release.
• Act as PKG internal SME for production issues related to deviations, dispositions, and response corrections.
• Supervise PKG document specialists; conduct performance evaluations and development discussions.

Skills

Packaging training

Regulatory compliance

CAPA management

Documentation

Training delivery

Education

Bachelor's degree in relevant science

Job description

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.