Sr Quality Assurance Specialist

Fresenius Kabi USA; Wilson (NC); Vor Ort; USD 74.000 - 104.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Jobbeschreibung

Job Summary

Provide Quality oversight to QC Metrology, Technology Transfer, and the laboratories (Chemistry and Microbiology) by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations.

Also provides support of the Empower network, laboratory network and standalone computer systems that support the laboratories. Coordinates installation and maintenance of standalone and networked computer hardware and software within the laboratories. Troubleshoots hardware and software problems and provides general user support as required.

Salary Range: $73,614 - $103,528

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.