Job Summary The Compliance Officer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the Production Unit from a FDA and global perspective. This function leads teams and projects to identify and correct cGMP inadequacies and ensure a high-level of compliance and Regulatory Audit readiness. The incumbent provides expertise in Deviation investigations, Complaints, Annual Product Review, and helps maintain the compliance of the CAPA system, as well as, reviewing and approving necessary documentation for regulatory correspondence. Salary Range: $73,614 - $103,528 Annually + 6% Annual Target Bonus 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 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 Completes Complaint and Event Investigations, including performing risk assessment, impact to product in the field and field safety, facilitating SME discussions, gathering an analyzing relevant data, performing root cause analysis and CA/PA determination. Leads internal audit teams to inspect and remediate system and process noncompliance in the plant. Responsible for the Site Master File Supports compilation of Annual Product Quality Reviews Ensures that deadlines are maintained for all project types and that extensions are properly justified and documented to maintain compliance. Maintaining site information for global databases Any other task as directed or requested by management or site leadership. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Requirements BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, Pharmacy, etc. 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Working knowledge of GMP, EU, and GLP, as well as FDA trends and guidelines Demonstrated experience in problem solving/trouble shooting High degree of attention to detail Candidate must possess strong interpersonal, written, and verbal communication skills. Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments. Good knowledge of MS Office programs, including Word and Excel 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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