Job Summary Salary Range: $80,000 to $100,000 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. Read more about our benefits here. Responsibilities The Compliance Offer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the production unit from an FDA and global perspective. This function leads teams and projects identity and correct cGMP inadequacies and ensures a high-level of compliance and regulatory audit readiness. The incumbent provides expertise in deviation and compliant investigations, annual product reviews, and helps maintain the compliance of the CAPA systems, as well as, reviewing and approving necessary documentation for regulatory correspondence. As needed, the Compliance Officer is independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the quality related deficiencies identified during the investigation process. Job Responsibilities: Completes / reviews deviation investigations and helps define necessary corrective actions to ensure complete, thorough, accurate, and timely evaluation of non-conformances and prevention of recurrence. Completes / reviews investigations. As part of each investigation, gathers information from all product, as well as the risk to future operations. Maintains complaint information in FK gCMW KabiTrack systems. Accountable for commitments agreed upon with department management to comply with closure targets Reviews and analyzes manufacturing and laboratory analytical documentation for accuracy and compliance to establish procedures Serves as the compliance SME for all internal audits and supports external and regulatory authority audits Coordinates the collection of information for all regulatory requests and assists in the compliance to commitments made to all regulatory authorities Leads internal audit teams to inspect and remediate system and process noncompliance in the plant Supports compilation of annual product quality review Responsible for ensuring compliance with relevant operating procedures Assists in the execution of GAP analysis and/or risk assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory, and maintenance and engineering, are in compliance with all regulatory requirements (e.g. cGMPS, FDA Guidelines, USP, etc.) Updates and maintains all related quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis All employees are responsible for ensuring the compliance to company documents, programs and activities related to health, safety, environment, energy, and quality management systems, as per their roles and responsibilities. Job Requirements: Bachelor's degree in Scientific or Engineering degree Minimum 3 (three) years of experience in the pharmaceutical industry in compliance, technical writing, and/or regulatory affairs The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment. 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 [email protected]. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

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