Job Summary POSITION SUMMARY The Coordinator is responsible for maintaining documentation of the manufacturing procedures and processes for manufacturing. This position strives to monitor changes in processes, revise documentation, and communicate to appropriate production area(s). They are responsible for all data analysis, supporting investigation efforts required to support the needs of the production department(s). Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Calculates results and reconciliations on batch records and reviews in accordance to current Good Documentation Practices Policy and SOP all documentation(including but not limited to Batch Records, Cleaning/Sanitization Attachments, section of Protocols related Department manufacturing processes, etc.) as required by production department. Supports all activities needed outside Hygiene Zone as required: documentation(attachments, logbooks, etc.) requests; brings vendors to Hygiene Zone; training related requests; monitors batch records corrections needs, and other non-routine requests (e.g. production supply from Central Storage ) Works within and maintains computer programs to calculate and trend required production data such as but not limited to: DPM reports, down-time reports, yield reports, re-inspection reports, daily production reports, etc. Keeps and maintains inventory of all stock items and order when necessary. Orders machine parts, tools and safety items at times. Completes and tracks Production weekly time sheets, logbooks reviews, unless directed otherwise by Department Manager. Performs daily data entry activities in LIMS, SAP, or other platforms to support manufacturing process as indicated by Department Manager. At times, identifies materials with SAP tags and coordinates movement of these materials with other departments, as indicated by Department Manager. Knowledge of good manufacturing practices and principles. Maintain all departmental filing and keeps production forms current. May perform this task for other Production departments at times, as indicated by Compounding Manager. Updates Compounding Standard Operation Procedures and evaluates and revises standard operating procedures as needed for method changes and/or corrective action. Conducts research required to support investigation of non-compliance issues or aids in determining root cause of non-compliance, developing corrective action, and/or assessing impact on product to complete investigation for management approval. Develops and executes special projects (e.g. down-time tracking, etc.) as assigned. REQUIREMENTS High School education required plus 1-3 years’ experience. Associate Degree preferred. Must have excellent computer literacy. (e.g. (Microsoft Excel and Word, PowerPoint, SAP, Lotus Notes, Outlook) Must be able to use computer programs and databases to calculate and trend production data and create presentations for management review. Knowledge of production batch records to reconcile and review results. Must be able to work independently and initiate self-developed projects to assist production operations. Strong written and oral communications skills are required. At times, able to lift and carry 40 pounds using proper technique, right tools and equipment. 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.