| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
To attain the position of Supervisor for the (GM), (Bowling Green, Ky) facilityPROFESSIONAL EXPERIENCEAlkermes, Inc., Wilmington, OHSupervisor, 03/25/2012-Present Acts as operational leader on the floor for assigned shift with direct responsibility for Manufacturing Associates and operations Provides effective, hands-on leadership to the production team as a whole in the production of pharmaceutical drug product Plans and supervises daily execution of tasks to support published production plan and supervises completion of work Supervise the GMP formulation of commercial scale batches; Ensures compliance with cGMP in the manufacture of products Supports the Line Manager complying with identified responsibilities (RACI) Ensures robust and timely communication of defined operational/planning activities associated with the execution of daily production Drives/Writes/Approves new SOPs, batch records, protocols in support of equipment and manufacturing processes Direct interface with support groups, including Facility & Process Maintenance, Engineering, Quality Assurance, Quality Control, Planning, Warehousing and Process Development, to ensure the operational status of the manufacturing area and production schedule Supports quality investigations, continuous improvement efforts and support group activities as they directly impact the functionality of the manufacturing area Initiate appropriate action when deviations occur, authoring investigations when required, to ensure the timely release of product and/or continuity of operation of the manufacturing line Support and perform validation efforts related to process improvements Ensure maintenance and upkeep of the facility and process employed within the area of responsibility In conjunction with Manufacturing training support, ensure opportunities for training for new and current operators Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical product Supervise, develop and evaluate Manufacturing Associates General knowledge of and ability to participate in customer, internal and FDA audits General knowledge of and ability to participate in SAP activitiesAlkermes, Inc., Wilmington, OHSenior Operator Production, 04/18/2005 03/25/2012 Production of pharmaceutical commercial batches. Assist with facility cleaning and operational maintenance. Assist with facility and process validations as required. Perform aseptic production operations and validations. Assist with environmental and water system monitoring as required. Assist with clean room sanitization as required.Pfizer, Inc, Franklin, OhSenior Operator, 08/1988- 08/2002 Lead other operators and small groups as directed by team leader. Production of pharmaceutical commercial batches. Assist with facility cleaning and operational maintenance. Assist with facility and process validations as required. Assist with environment and water system monitoring as required. Assist with clean room sanitization as required.Ran distillery for reprocessing of waste Alcohol.EDUCATION & CREDENTIALSGraduated from Monroe High, OhioCERTIFICATIONSOPEX Lean Six Sigma Greenbelt, 2019Manager Influence on trainingSAP qualified |
