Senior QA & Lab Compliance Specialist

Fresenius Kabi USA; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal/

Health benefits: medical, dental, and视

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA seeks a Quality Oversight professional to support QC Metrology, Technology Transfer, and Chemistry and Microbiology laboratories. You will coordinate standalone and Empower network systems, troubleshoot hardware/software, and ensure compliance with applicable regulations.

Responsibilities include coordinating installations, maintaining documentation, and providing high-level user support to enable quality product release and process improvements across the plant.

Qualifications

• Experience with QC metrology and technology transfer in a regulated environment.
• Knowledge of GMP regulations and compliance practices.
• Experience supporting laboratory computer systems and instrument software.

Responsibilities

• Oversee Tech Transfer, process validation, cleaning validation, and continuous process verification.
• Oversee Chemistry: method validation, equipment qualification, metrology, stability program, raw material release.
• Oversee Microbiology: filter validation, method validation.
• Review and approve protocols, deviations, and change controls; audit trails for analytical equipment.

Skills

Quality oversight

Metrology

Technology Transfer

Laboratory networks

cGMP compliance

Tools

Empower network

Laboratory software

Job description

Fresenius Kabi USA seeks a Quality Oversight professional to support QC Metrology, Technology Transfer, and Chemistry and Microbiology laboratories. You will coordinate standalone and Empower network systems, troubleshoot hardware/software, and ensure compliance with applicable regulations.

Responsibilities include coordinating installations, maintaining documentation, and providing high-level user support to enable quality product release and process improvements across the plant.