Senior QA Specialist - Labs, Metrology & Tech Transfer

Fresenius SE & Co. KGaA; Wilson, Northern (NC, KY); Hybrid; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid time off

Employee assistance

Job summary

Fresenius Kabi in Wilson, NC seeks a Quality Oversight professional to support QC Metrology, Technology Transfer, Chemistry and Microbiology labs, ensuring compliance with applicable regulations.

You will coordinate installation and maintenance of standalone and networked laboratory computer systems, troubleshoot issues, and provide high-level user support, while maintaining Empower network administration for the site.

Responsibilities

• Oversee Technology Transfer activities: validation, process improvements, packaging development, and thermal cycling
• Chemistry: method validation, equipment qualification, metrology, stability program, USP updates
• Microbiology: filter validation, method validation
• Collaborate with plant groups to produce quality products
• Review/approve protocols, investigations, raw data and reports
• Review/approve changes in batch records and implementation of new batch records
• Review deviations, OOS, OOT, and change controls
• Audit trail review of analytical equipment
• Support laboratory computer systems
• Maintain Empower network administrator support at the site
• Provide high-level user technical support
• Review operational systems for quality and compliance; software upgrades
• Audit network for cGMP compliance
• Create and maintain documentation for procedures and systems
• Perform other duties as assigned by management.

Job description

Fresenius Kabi in Wilson, NC seeks a Quality Oversight professional to support QC Metrology, Technology Transfer, Chemistry and Microbiology labs, ensuring compliance with applicable regulations.

You will coordinate installation and maintenance of standalone and networked laboratory computer systems, troubleshoot issues, and provide high-level user support, while maintaining Empower network administration for the site.