Work Schedule
12 hr shift/nights

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Lead Machine Operator (Nights)

Our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve humankind by enabling our customers to make the world healthier, cleaner and safer.

• Performs tactical planning to make decisions based on encapsulation schedule, staffing, product mix, and manufacturing priorities in order to meet high Quality, high Productivity, and On Time Delivery dates.
• Checks encapsulation schedule daily in order to plan for effective execution of activities.
• Assigns associates to work stations to meet production requirements.
• Checks log books in each room for proper completion and accuracy.
• Verifies that no foreign capsules are remaining in any room following a changeover and that all equipment is clean and the documentation is complete and accurate.
• Notifies supervisor of any problems, including poor quality, compliance risks, data integrity concerns etc.
• Collects data for shift production and inputs information into computer
• Verifies, inputs and corrects information in SAP.
• Reviews Batch Production Records (BPRs) accurately and thoroughly, with Right First Pass metrics in mind. Submits detailed review of completed BPR paperwork to In Process Quality Assurance (IPQA).
• Investigates and writes events and CAPAs in Trackwise, must be able to efficiently and effectively write and obtain approval of GMP notes and memos as needed.
• Coordinates and/or supplies materials (towels, paperwork, etc.) to the encapsulation rooms to minimize down time.
• Verifies the product quality of in process batches multiple times throughout their shift. Quality checks include review of fill weight statistics, seam thickness values, and physical capsule attributes.
• Conducts periodic checks throughout shift of all fill weight scales, seam microscopes, and all associated equipment for proper set-up and operation.
• Meets with supervisor to receive instructions and to exchange production information. Provides back-up for supervisor in their absence.
• Conducts detailed Training sessions for workers in equipment operation and when SOPs have been revised.
• May perform duties of absent associates in order to maintain production standards and goals.
• May perform other reasonable, related business duties as assigned.
• Perform periodic GEMBA walks of the encapsulation area in order to find opportunities for improvement and GMP compliance.

• High School diploma or GED
• Ability to pass DEA requirements
• Ability to read, write, and speak English fluently