Manufacturing Specialist
$31,200,000–$41,600,000 year
On-siteLexington, Kentucky, United States
Job Summary
Conduct direct support of process improvement and compliance directives for manufacturing activities at the KDD Lexington facility. Execute on-the-floor investigation triage for deviations, complaints, OOS, and OOT, performing root cause analysis and managing corrective/preventive actions. Review and revise Batch Records, SOPs, and manufacturing processes while collaborating with Quality Assurance and technical experts to ensure compliant commitments. Lead continuous improvement initiatives on the manufacturing floor and implement change management strategies to train and support technician staff. Requires 3+ years of GMP experience and a BS degree in Engineering or related discipline.
Required Qualifications
- 3+ years GMP experience
- Knowledge of GMP regulations and regulatory requirements in pharmaceutical manufacturing
- Ability to make sound decisions regarding compliance-related issues with moderate supervision
- Strong attention to detail
- Ability to manage multiple priorities and tasks in a dynamic environment
- Strong communication skills (written and verbal)
- Strong organizational skills
- High level of personal/departmental accountability and responsibility
- Experience with programs such as Access, Excel, ERP, Power BI, Power Aps and an electronic document management system
Desired Qualifications
- BS degree in Engineering, Business/Operations, or related discipline
- Lean manufacturing, continuous improvement experience
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