Principal Specialist, Packaging Training (Onsite) – Athens, GA | 6-Month Contract | GMP | Training & Compliance | Pharmaceutical Manufacturing

Location: Athens, GA (Onsite)
Job Type: 6-Month Contract
Company: Sigma Inc.
Competitive Pay: Based on Experience

Join Sigma Inc. as a Principal Specialist, Packaging Training!

Sigma Inc. is seeking an experienced Principal Specialist, Packaging Training & Compliance to support a leading pharmaceutical manufacturing client in Athens, GA. This onsite contract opportunity is ideal for professionals with strong experience in GMP manufacturing, packaging operations, training program management, compliance, CAPA, deviations, document control, and quality systems.

If you have a background in pharmaceutical, biotechnology, biologics, vaccines, or regulated manufacturing environments and are passionate about ensuring compliance, training excellence, and continuous process improvement, we'd love to hear from you!

Key Responsibilities

• Lead the Packaging (PKG) documentation team supporting daily production operations.
• Review manufacturing batch records for accuracy, completeness, and regulatory compliance.
• Review and support:
  • Deviations
  • Change Controls
  • CAPAs (Corrective and Preventive Actions)
  • Product Holds
  • Product Dispositions
  • Documentation revisions
• Develop, maintain, and continuously improve Packaging Training Programs.
• Ensure all Packaging personnel maintain current training and compliance requirements.
• Manage training records utilizing the LOS Learning Management System (LOS).
• Track On-the-Job Training (OJT) outside the LOS system.
• Implement corrective actions to address audit findings and deviation trends.
• Serve as the Packaging Subject Matter Expert (SME) for routine production and compliance issues.
• Support product release activities through documentation review and quality verification.
• Lead document creation, revision, and controlled documentation processes.
• Conduct performance discussions and support development of Packaging Documentation Specialists.
• Collaborate with Production, Quality Assurance, Regulatory Affairs, and Operations teams.
• Ensure compliance with company policies, GMP regulations, FDA, USDA, EU, EMA, and other applicable regulatory requirements.
• Promote continuous improvement, operational excellence, and inspection readiness.

Required Qualifications

• Bachelor's Degree in a Scientific Discipline from an accredited institution.
• Experience in pharmaceutical, biotechnology, biologics, vaccines, medical device, or regulated manufacturing environments.
• Strong knowledge of:
  • Good Manufacturing Practices (GMP)
  • Packaging Operations
  • Batch Record Review
  • Compliance Documentation
  • CAPA Management
  • Deviation Investigations
  • Change Control
  • Product Release
  • Document Control
• Experience developing and maintaining employee training programs.
• Experience maintaining training records and compliance documentation.
• Strong leadership and mentoring skills.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and problem-solving abilities.
• Ability to work effectively in cross-functional teams.
• Demonstrated commitment to quality, compliance, and continuous improvement.

Preferred Qualifications

• Experience with pharmaceutical packaging operations.
• Experience using Learning Management Systems (LMS), preferably LOS.
• Experience supporting FDA, USDA, EMA, or EU regulated environments.
• Experience leading documentation teams.
• Experience supporting internal and external regulatory inspections.
• Knowledge of Quality Management Systems (QMS).
• Lean Manufacturing or Continuous Improvement experience.

Required Skills

• GMP Compliance
• Pharmaceutical Manufacturing
• Packaging Operations
• Packaging Compliance
• Packaging Documentation
• Batch Record Review
• Training Program Development
• Learning Management Systems (LMS)
• LOS System
• CAPA
• Change Control
• Deviation Management
• Product Release
• Product Disposition
• Documentation Control
• SOP Development
• Technical Writing
• Regulatory Compliance
• FDA Regulations
• USDA Regulations
• EMA Regulations
• EU Regulations
• Quality Assurance
• Quality Systems
• Continuous Improvement
• Root Cause Analysis
• Leadership
• Team Management
• Cross-functional Collaboration
• Microsoft Office Suite