Operations Specialist

Summary

This position is responsible for providing the direction, organization, alignment, monitoring and cGMP compliance to ensure the successful, cost effective, timely and safe processing of customer orders. The position audits production room documentation, checks equipment challenges and hourly in-process inspections have been performed, ensures samples have been taken, and reviews room for 5S Compliance. These associates are responsible for performing real time batch record and documentation review and or co-signs during batch processing in order to drive improvements into our Right First Time (RFT) metrics. They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts.

Essential Duties and Responsibilities

• Perform operational production room approvals after product and lot changes
• Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
• Ensure equipment is packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications
• Review batch record 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
• Confirm package (unit) functionality (perfs, peel, push, seals, etc.)
• 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 PDR'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
• Report quality event notifications for issues encountered on the production floor to OPS Mgmt
• Support operations by creating JDE labels for production
• May perform duties of Quality Coordinator
• 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 regards 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

Computer Skills

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