Sr Quality Assurance Specialist

Posted 2 Days Ago
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Wilson, NC, USA
In-Office
74K-104K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Provides quality oversight for QC metrology, technology transfer, chemistry, and microbiology laboratories. Reviews and approves validation protocols, investigations, batch records, deviations, OOS/OOT results, and change controls. Supports the Empower network and laboratory computer systems, including hardware and software installation, troubleshooting, user support, audit trail reviews, system compliance audits, upgrades, and documentation under cGMP requirements.
Summary Generated by Built In
Job SummaryProvide 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.

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The Company
HQ: Bad Homburg v. d. Höhe
21,388 Employees

What We Do

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint

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