Packaging Quality & Compliance Manager job in Athens, GA
Athens, GA CorTech LLC
| Job Ref: | 376278 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | Market/Per Hour |
| Remote: | No |
Location |
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| City: | Athens, GA |
| Post Code: | 30601 |
| Map: |
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Description |
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The Packaging Quality, Training & Compliance Manager provides leadership and oversight for packaging documentation, training, compliance, and quality activities supporting day-to-day production operations. This role leads the Packaging (PKG) documentation function and serves as a key subject matter expert for packaging operations. The position is responsible for batch documentation review, deviations, change controls, CAPAs, product release activities, and the creation and revision of controlled documents in accordance with company procedures and applicable regulatory requirements. The ideal candidate has strong experience in GMP-regulated manufacturing, packaging operations, quality systems, documentation, and employee training. Key Responsibilities Packaging Compliance & Documentation Lead the Packaging documentation team and provide direction for daily operations. Review and approve manufacturing and batch documentation to support product release. Create, review, revise, and maintain packaging-related documents in accordance with established procedures. Ensure documentation complies with applicable regulatory requirements and company standards. Support production operations by resolving routine documentation and compliance issues. Serve as the Packaging internal subject matter expert (SME) for documentation and compliance-related matters. Training & Development Develop, implement, and maintain a comprehensive Packaging training program. Ensure training programs meet company, regulatory, and packaging requirements. Maintain supplemental training records and ensure personnel remain current on required training. Track required training through the LOS system and maintain separate records for On-the-Job Training (OJT). Identify training gaps and implement appropriate corrective actions. Support employee development and provide guidance to Packaging team members. Quality & Compliance Support and oversee investigations related to deviations and production issues. Develop and implement effective CAPAs to address recurring or potential compliance issues. Support change controls and assess impacts to packaging operations. Assist with product holds, dispositions, and other activities required for product release. Participate in audits, inspections, and compliance activities as needed. Ensure all activities are performed in accordance with applicable GMP and regulatory requirements. Identify potential compliance risks and escalate issues appropriately. Production & Product Release Oversee review and approval of manufacturing records and related documentation. Support product release activities in accordance with applicable procedures. Act as a Packaging SME for routine production issues that may result in deviations, product holds, dispositions, or corrective actions. Partner with Production, Quality, and other cross-functional teams to resolve issues and maintain production continuity. Team Leadership Lead Packaging document specialists through daily activities and priorities. Provide coaching, guidance, and support to team members. Conduct or assist with performance evaluations and employee development discussions. Promote a culture of quality, compliance, accountability, and continuous improvement. Qualifications Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Engineering, Quality, Manufacturing, or a related field preferred. Significant experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related manufacturing environment. Experience with packaging operations, quality systems, manufacturing documentation, or production compliance. Strong knowledge of GMP requirements and regulated manufacturing practices. Experience with deviations, CAPAs, change controls, and batch record review. Experience developing or managing employee training programs. Experience supporting product release or manufacturing documentation review preferred. Strong written and verbal communication skills. Strong organizational skills and attention to detail. Ability to work cross-functionally with Production, Quality, Training, and other departments. Demonstrated ability to lead projects, resolve compliance issues, and drive continuous improvement. High level of professionalism, integrity, and ethical judgment. Regulatory & Compliance Expectations All company activities must be performed in accordance with applicable regulations, including relevant GMP, USDA, EU, EMA, and other regulatory requirements, as well as company policies and procedures. Employees are expected to maintain high ethical and professional standards and promptly report observed or suspected violations to management. | |
ref: (376278)
127 days ago
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