Senior QA Specialist – Lab Systems & Process Validation

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

Job summary

Fresenius Kabi USA is seeking a Quality oversight professional to lead QC Metrology, Technology Transfer, and the Chemistry and Microbiology laboratories, ensuring compliance with applicable regulations and delivering consistent, high-quality results.

The role also provides support for the Empower network and laboratory computer systems, coordinates installation and maintenance of hardware and software, troubleshoots issues, and reviews protocols, deviations, OOS, and change controls to uphold

Qualifications

• Quality oversight of QC Metrology, Technology Transfer, and Chemistry and Microbiology laboratories.
• Regulatory compliance and quality standard adherence.
• Support for Empower network and laboratory computer systems.

Responsibilities

• Support the plant by overseeing the following systems, but not limited to:
• Technology Transfer: process validation, cleaning validation, continuous process verification, process improvements, packaging development, thermal cycling
• Chemistry: method validation, equipment qualification, metrology, stability program, raw material, component release, USP updates
• Microbiology: filter validation, method validation
• Work in partnership with all plant groups towards the goal of producing quality products by:
• Reviewing/approving protocols, investigative studies, raw data and reports
• Review/approve changes in production batch records and implementation of new batch records
• Review/approve deviations, OOSs (out of specification), OOTs (out of trend), OOTs (out of tolerance) and change controls
• Perform audit trail review of all analytical equipment used in the laboratories
• Support computer systems that support the laboratories
• Maintains administrator support for the Empower network specific to the site, exclusive of IT’s responsibilities for system backup and support
• Provide high level technical support for all users
• Review operational systems for quality and compliance to standards and software upgrades
• Audit network for compliance to cGMP regulations
• Create and maintain documentation for all procedures and systems that support the laboratories
• Perform other duties as assigned by Management.

Job description

Fresenius Kabi USA is seeking a Quality oversight professional to lead QC Metrology, Technology Transfer, and the Chemistry and Microbiology laboratories, ensuring compliance with applicable regulations and delivering consistent, high-quality results.

The role also provides support for the Empower network and laboratory computer systems, coordinates installation and maintenance of hardware and software, troubleshoots issues, and reviews protocols, deviations, OOS, and change controls to uphold