Sr Quality Assurance 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

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.

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, and wellness 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.