Description:
Job Summary
Performs all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conduction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.
Scope of Job
The production operator is a position within the manufacturing & packaging departments that is solely responsible for the operations of equipment utilized in the production and packaging of oral solid dose products.
Key Accountabilities
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Documentation 40%
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Executes Batch Record and logbook documentation with detail and accuracy
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Performs required in-process product quality checks and documents accurately
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Executes procedures to complete tasks in a safe and efficient manner.
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Operation of Equipment 50%
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Executes the procedures used to clean pharmaceutical production & packaging equipment and facilities
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Executes procedures to complete tasks in a safe and efficient manner.
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Operates pharmaceutical production & packaging machinery and executes procedures for manufacturing such as dispensing, mixing, granulation, coating, encapsulation, milling, blending, compressing, printing, laser drill inspection and the like.
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Execute in changeovers
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Maintains production/packaging reporting for assigned work unit operation.
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Teamwork 10%
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Work in collaboration with others as part of a team
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Assists with on the job training of other production trainees and operators
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Effectively communicates issues to supervisor
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Assists in identification and implementation of continuous improvement opportunities
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Performs other related duties as assigned to meet departmental and Company objectives
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Other duties assigned
Requirements:
Education, Experience and Qualifications
Required
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High School Diploma / GED
Experience
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0-2 years of Production/Packaging experience is an asset. Strong background in solid dose manufacturing or packaging preferred. Must be capable of working various hours/shifts and weekends when necessary.
Specific Skills
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Knowledge of the Metric and English weighing and measurement systems
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Basic understanding of mechanical machinery and the operating principles of control systems
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Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages
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Ability to use a calculator and computer systems (Word, Excel, SAP, Outlook, SharePoint, Master Control, Success Factors)
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Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation
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Accurate and precise in recording data and batch information
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Proficient in reading and writing English to understand work instructions and document results
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Demonstrated ability to operate pharmaceutical processing equipment and meet required standards of cGMP’s
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Demonstrate understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators
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Complete visual inspections and accountably
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Dispensing - Demonstrates the ability of cleaning and setup of rooms and downflow booths. Can complete basic transactions in SAP. This includes Eol for lots.
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Granulation - Capable of disassembly, cleaning, reassembly, operating, and basic troubleshooting of three pieces of machinery (screeners, binlifts, bin blenders, and/or drum inverters). Additionally, must be able to accurately complete accountability and SAP weighing of drums; inputting labor hours; and completion of container check in.
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Encapsulation –The ability to operate, perform in-process checks and accountability calculations for IMA micro-tablet capsule filling, operate, disassemble and basic trouble shooting of a powder/pellet dosator. Set-up, clean, operate all check weighing systems (CWI, KKE, IMA)
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Compression – The ability to operate, disassemble, reassemble and basic trouble shooting of a single sided press (Fette 2200, Korsch XL 200/400) with multiple products (Year 1). Demonstrate the ability of operating, disassemble, reassemble and basic trouble shooting of 2 single sided presses (Fette 2200, Korsch XL 200/400) with more than one product or an additional press (Fette 3200/3090) not utilizing mutli-tipped tooling (Year 2)
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Coating – demonstrates the ability of cleaning and assembly of solution prep vessels and equipment and serves as a secondary operator. Capable of operating, cleaning and assembly of one coater with multiple products
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Fluid Bed – demonstrates the ability of cleaning and assembly of solution prep vessels and equipment and serves as a secondary operator. Capable of operating, cleaning and assembly of the sub-coat, enteric coat and top spray processes
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Print/Laser Drill/Inspection – capable of operating/cleaning, disassemble and reassemble of two machines including accountability and SAP weighing of drums
Physical Requirements
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Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, pull, push, grasp, feel, talk and hear.
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Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
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Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point.
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Must have the ability to identify and distinguish colors.
- Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
- Must be able to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
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.
The above description is intended to describe the general content and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Management has the right to assign or reassign duties and responsibilities to this job at any time.
