Job Summary

Responsible for supporting routine operations of the Manufacturing Department, with a focus on batch record documentation flow, logbooks, and trending of Key Performance Indicators. Provides support to the Director of Manufacturing, Production Managers, and Supervisors as requested on special projects.

Primary supervision will come from the Director of Production. Other projects may be requested by Production Managers and Supervisors. No direct supervisory responsibility. Must effectively lead employees indirectly to achieve goals.

Hourly Range: $18.79-$26.36

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Review of batch records for accuracy as they are completed, may include completion of batch reconciliation, and prior to disposition to QA.
• Review all production logbooks for accuracy and missing data prior to disposition to QA.
• Review, revise and update SOP's within Documentum, tracking through training process and implementation.
• Data collection, entry and reporting on production line efficiencies.
• Coordinates Batch Record completion between varying Supervisors and production areas.  Also locates specific batch record information for investigations, audits, etc.
• Verify and enter data collected from batch records, downtime sheets, fill reports and manning sheets to provide necessary production reports such as weekly batch record accountability by supervisor.
• Assist supervision with SAP EWM entries for material ordering and consumption.
• Responsible for developing, analyzing and maintaining the smooth flow and accumulation of data concerning production related areas.  This data is used to create daily, monthly and quarterly reports and presentations.
• Responsible for daily gathering and tracking data from varying departmental reports, such as DPMs, AQLs, and Line Yields for both production and packaging, to create presentations for quarterly trend reporting.
• Generates daily, weekly, and monthly metrics, such as weekly compliance report, individual line yields by month, and weekly combined line yields.
• Supports the Director of Manufacturing by collecting information concerning Production activities.
• Works with area supervisors to assist in daily operation of the department as needed, e.g. missing documentation and errors, creating signs for production areas.
• Responsible for coordination of short-term departmental goals with the assistance of the Department Director, Managers, or Supervisors.
• Prepares appropriate reports and documentation, such as Annual Product Reviews, MRDR tracking and any other required documentation. 
• Responsible for reviewing, revising and updating SOP's within Documentum, tracking through training process and implementation.
• Interacts with other plant disciplines such as QA., PPIC, and others to achieve project and departmental goals.
• Performs duties such as typing correspondence, reports, and memos on behalf of the   Production Department.
• Maintains a central file for information pertaining to the Production Department.
• Process Purchase Orders / Check requisitions for Production Department.
• Maintains office supplies for Production Operations. 
• Assumes additional responsibilities as required.

Requirements

• H.S. Diploma required; AAS Degree preferred.
• 1 to 3 years pharmaceutical experience or within similar industry required.
• Proficient to master level user in Microsoft Office, particularly Excel.
• Excellent written and oral communication skills.
• Strong analytical organizational skills.
• Ability to prioritize objectives and accomplish goals.
• Capacity to multi-task in a fast paced 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.

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.