Production and Industrial - Operator II, Manufacturing

Job Description: Operator II, Manufacturing Job Description - Filling


Discover Impactful Work
The Operator II position will interact and work closely with production leads and managers within Manufacturing Services department to support production demand and ensure achievement of company goals following the 4i values.

A Day in the Life
• Responsible for signatures as review on SOP's and other work instruction documents.
• Understands and can communicate workflow and technologies used in the production environment.
• Manufacture and/or test complex products following cGMP and completes all vital documentation in accordance with Quality System. Records information such as time and date performed.
• Share standard process.
• Set up and operate production floor equipment including troubleshooting and adjustments under the direction of a Production Operator Lead or Supervisor
• Read and understand work orders to successfully set up materials on-line, verify and count the amounts required as per work order.
• Inspect material and products at each set up of production process.
• Assist the Production Operator Lead in the assignment of jobs as required by their assignment on the production line.
• Close and seal containers, sort bundles or filled containers, label containers, container tags, or products as needed.
• Pack special arrangements or selections of products as needed.
• Make necessary entries in the QAD System related to material use.
• Line Clearance - responsible to reconciliation and disposal of materials related to the job.
• Clean and sanitize work areas, machines and printers as needed or directed.
• Work with Production Lead, Production Operator II's and Sr Operator as a team to solve Production Floor scheduling, equipment, and logistic issues.
• Support Engineer in process improvement and equipment validation activities.
• Responsible for following ISO/cGMP Quality System Regulations with focus on SOP completion accuracy, product quality, and housekeeping activities.
• Follow all written procedures. Report discrepancies in procedures (SOP's, batch records, etc.) to the Area Supervisor and perform all work activities in a safe manner and wear personal protective equipment as required.
• Participate in Practical Process Improvement (PPI), Lean, and 5-S programs while working with other departments to troubleshoot processes/procedures to deliver recommended solutions
• Perform other job duties as required by department and/or Management

Keys to Success
• High School Diploma or equivalent required.
• Minimum of 1 year of direct work experience in manufacturing, operations, production, lab setting.
• Preferred:
Direct experience in a cGMP environment, Good Documentation Practices (GDP), and Good Warehouse Practices.
Direct machine operation experience.
• Knowledge of Microsoft Word and Excel is required.
• Ability to use electronic management systems such as QAD and Oracle to print all required documents to complete the daily work as indicated in the production schedule.
• Ability to read, write and comprehend English language, both written and verbally.
• Ability to read and interpret as related to documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to understand and carry out instructions furnished in written, oral, or diagram form.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to handle multiple tasks and react appropriately to changing priorities and impending deadlines.
• Must be highly collaborative in teamwork environment.
• Ability to perform basic math.
• Ability to stand for sustained periods of time

Physical Requirements / Work Environment
• Able to lift up to 50 lbs. without assistance.
• May work in cold environments (as low as -20C) and around loud-noise equipment.
• Personal protective equipment (PPE) such as steel-toe shoes, lab coats, gloves, safety glasses, and ear protection required.
• Controlled Substance Handling: This role involves handling, management, and oversight of controlled substances (Schedules I-V) in accordance with DEA, FDA, and Thermo Fisher guidelines.
• Exposure to Controlled Substances: Proper safety protocols and protective measures must be strictly followed.
• Safety Protocols: Adherence to all safety procedures is mandatory to ensure a safe working environment.
• Background Check: Successful completion of a background check, including screening related to controlled substances, is required.
• Standard Shift: 6:00AM to 2:45PM, Monday Through Friday
Must be flexible to support overtime, weekend overtime and swing shifts hours (4pm-4am) as production demand requires.
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