Production Supervisor

Essential Duties and Responsibilities

• Perform operational production room approvals after product and lot changes
• Verify first piece inspection to ensure finished goods code, format, and expiration date are correct
• Ensure products are packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications
• Review batch record (MPI's) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately
• Review sampling pages to ensure samples have been taken, labelled, and documented appropriately
• Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely
• Check to ensure portable equipment has been cleaned and documented correctly on quality form
• Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment
• Ensure recovery stations are segregated from product flow
• Confirm bulk material and components for job are correct and kept covered
• Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible
• Review temperature and humidity data to ensure within acceptable job parameters
• Identify proactively gaps in batch records and TER's to mitigate deviations and documentation errors
• Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed
• Support Root Cause Analysis as needed
• Perform/support end of shift BR review and support/complete FORM-0001908 (QA 903)
• Report quality event notifications for issues encountered on the production floor to OPS Mgmt
• Support operations by creating JDE labels for production and act as on floor SME for JDE transactions
• May require overtime and/or weekend work
• Must have knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules
• Must be dependable in work attendance
• May perform duties of a production Supervisor and or relieve supervisors of ancillary tasks
• Perform other duties as assigned by Manager/Supervisor

Education or Equivalent

• High School Diploma required
• 2 - 4 years relevant experience in production, equipment and or process
• Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred

Language Skills

• Must possess good analytical skills and excellent verbal and written communication skills
• Must demonstrate effective listening, coaching and interpersonal communications skills

Knowledge/Skills Requirements

• Must be dependable and show initiative to improve safety, quality, through put and cost performance
• Must be willing to work overtime and flexible in regard to working on all 3 shifts
• Able to balance multiple issues simultaneously in a fast-paced environment
• Needs good problem-solving skills, should be detail oriented and well organized
• Must have excellent attention to detail and possess detailed knowledge of cGMP documentation and the completion thereof
• Must have excellent interpersonal skills able to lead and direct union associates and communicate effectively with all levels of management

Computer Skills

Must be computer literate with past experience using MS Office, Lotus Notes, spreadsheets and ERP systems.