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. Responsibilities Reviews and analyzes manufacturing and laboratory analytical documentation for accuracy and compliance to established procedures Reviews Deviation investigations and helps define necessary corrective actions to ensure complete, thorough, accurate and timely evaluation of non-conformances and prevention of recurrence 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. Responsible for the Site Master File Supports compilation of Annual Product Quality Reviews REQUIREMENTS Bachelor’s Degree in a Scientific or Engineering Discipline is required Three years previous experience in Pharmaceutical or related field Computer Skills Excellent Written and Verbal Communication skills Demonstrated experience in problem solving/trouble shooting High degree of attention to detail 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 match, and wellness program. 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 lifesaving medicines and medical 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. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition. Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.