Job Summary Under direct supervision, provide clerical and administrative support for documentation system under cGMP and support the Quality System. Issue and control documents according to established procedures. Administer document routing and review process. Research and collate file records as needed. May also operate a desktop computer using word processing software. Fill document requests. Responsibilities Maintain files (Filing Master, history files and artwork). Issue document numbers. Create and maintain document indexes. Provide clerical work (i.e. fax and copy documents) Fill document copy requests. Assign quality numbers. Retrieve quality records. Perform final quality release of production units Perform quality support activities, such as performing production containment activities Provide administrative and other support such as document research requests, scanning, and archiving records and adhere to document control procedures. Support customer complaint investigation Supports label proof approval and first article approval Handle problems, routine in nature, using established processes and procedures. Other duties as assigned. 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 High School Diploma/GED Ability to work on a team is essential. Possess effective writing and verbal communication skills, in addition to personal conflict resolution skills. Ability to notice errors in documentation and filing, and to take appropriate corrective actions. Must be detail oriented and able to multitask. Handle problems routine in nature using establish processes and procedures. Able to make judgments based on past experiences, established practices, and procedures. Ability to read and understand SOPs, GDPs, and Configuration manuals. Must be able to prioritize multiple projects and tasks. 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 (www.CaringForLife.us) 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 40,000 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 HRLakeZurich@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.