Batch Records Auditor

Reposted 2 Days Ago
Be an Early Applicant
Wilson, NC, USA
In-Office
39K-55K Annually
Entry level
Healthtech • Pharmaceutical
The Role
Conduct analyses and inspections of raw and packaged materials, ensuring adherence to quality standards and regulatory compliance for manufactured products.
Summary Generated by Built In
Job SummaryConducts analyses and inspections of raw and packaged materials, executes quantitative and qualitative assays, and ensures adherence to quality standards and regulatory compliance for manufactured products.
Salary Range: $$39,083-$54,829
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and 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

The Specialist performs some or all of the following accountabilities as assigned:
• Performing analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property
• Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance
• Performing required inspections, checks, analysis and documentation of studies
• Preparing and monitoring quality statistics and reports
• Reviewing production records for conformance to procedures
• Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures

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.

Skills Required

  • Experience in quality assurance
  • Knowledge of regulatory compliance
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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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