The Operator III is an expert level operator position. The Operator is responsible for performing any combination of the following without any supervision: prepares, processes, inspects, and packages product. Monitors and responds to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, loading or unloading materials. This person is expected to adhere to all SOPs, cGMPs, plant quality, safety, and documentation systems requirements. The Operator will clean equipment and work area.
- Must be able to perform various functions of a highly repetitive nature while maintaining concentration of task.
- Must adhere to all gowning/uniform requirements in assigned area.
- Must be able to process, inspect, and/or package commodities thru various processing stages.
- Must be able to operate minor assembly type machines in or out of clean room type environment.
- Must be able to perform detailed inspection of commodities.
- Must be able to operate pallet jack, motorized pallet jack and forklift
- Work overtime and shift work as business needs require
- Must be able to adapt to changing tasks and schedules
- Under direct supervision, fills out all cGMP and non- cGMP documentation.
- Performs cleaning of equipment according to SOP’s
- Maintains a cGMP readiness of production area through effective housekeeping and organization
- Other duties as assigned
Education, Experience and Qualifications
- High School Diploma / GED
- Certifications: forklift
Work experience (type of industry and years of experience) required for the job.
- High school diploma or equivalent required with 3-5 years of Pharmaceutical /4-5 years of related production experience and/or training preferred
- Must develop effective working knowledge of production processes and comply with all pertinent Standard Operating Procedures (“SOPs”), and manufacturing/packaging batch records.
- Demonstrates attention to detail and accuracy.
- Teamwork - Balances team and individual responsibilities.
- Uses equipment and materials properly.
- Adapts to changes in the work environment.
- Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, and decimals
- Maintains proper gowning and hygiene to ensure integrity of the product as per company policies
- The employee must routinely lift and/or move up to 70 pounds
- The employee will be required to perform daily tasks requiring repetitive motion and should take every effort to be informed and take necessary precautions to avoid injury.
Scope of Decision-Making:
- Decisions require little judgment. Understand and follow basic/routine instructions and use basic/routine equipment involving few decisions. Duties are extremely standardized and performed under direction supervision or review.
Level of Supervision Provided:
- Individual contributor, not responsible for the work of others.
- Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters. Occasionally contacts individuals outside the department or functional area.