Sr Quality Assurance Specialist

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

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 andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.