Job Summary The QA Compliance Specialist works with the Compliance Management Team to Identify and correct cGMP inadequacies at the Production Unit, as well as, helping to develop and implement Quality Systems designed to maintain a high level of internal and external audit readiness and Regulatory Compliance. The position is responsible for facilitating the approval of the Annual Product Quality Review (APQR) and the development of relevant systems designed to maintain compliance with the various APQR procedures and Regulatory Agency requirements. The QA Compliance Specialist participates in compliance initiatives based on new regulations, guidance documents and industry standards and applies them to the six systems when directed. The position will also provide support for event initiation, investigations, and internal audits. Responsibilities Participates in multi-functional project teams as a Compliance representative as directed by the Compliance Management Team Responsible for compiling, processing and facilitating the Annual Product Quality Review in a timely manner Assists in ensuring adherence to regulatory requirements and industry guidance through the review of appropriate documentation and internal audit activities as directed by the Compliance Management team Responsible for the compliance of the storage and archiving of documents with company policy and Regulatory Agency requirements Assists and coordinates compliance initiatives based on new regulations, guidance documents and industry standards as they apply to site Quality Assurance Participate in FDA readiness audits as required by the Compliance Management team Performs other duties as assigned by Compliance Supervisor, Manager, or Director of Quality Assurance 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. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

Compliance Specialist.

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