GMP Packaging (PKG) Documentation Specialist

VARITE • Athens, GA

4d • Onsite

About The Position

VARITE is looking for a qualified Principal Specialist, Packaging Training in Athens, GA. The client is a global, research-driven pharmaceutical company that focuses on developing innovative medicines in areas such as human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing. VARITE, established in 2000, is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With over 850 global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services. This role is a 6-month contract with a possible extension, paying $30.66 - $32.85/hr. on W2. Only USC or GC are eligible.

Requirements

• Bachelor’s degree from an accredited institution in a relevant scientific discipline.
• Demonstrated high ethical and professional standards with all business contacts in order to maintain the company's excellent reputation in the community.
• 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.

Nice To Haves

• Experience with LOS System for tracking training.
• Experience tracking On the Job Training (OJT) separately outside of LOS.

Responsibilities

• Lead the Packaging (PKG) documentation team to support the production line 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 all personnel are up to date on all compliance requirements.
• Implement 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.
• Lead PKG document specialist through daily operations.
• Conduct or assist with performance evaluations and development discussions.

Benefits

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.
• Employee referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Principal