JOB SUMMARY
The Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.
Key Accountabilities:
- Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.
- Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
- May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.
- Cleans manufacturing equipment and facilities according to established SOPs.
- Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.
- Executes written SOPs to ensure the purity of materials involved in the manufacturing process.
- Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
- Executes machine changeovers from batch to batch.
Requirements:
- HS diploma, GED or College Associate Degree
- Minimum of 3-7 years of OSD pharmaceutical manufacturing (cGMP) experience
- Forklift certification may be required for certain jobs.
- Strong background in solid dose manufacturing (OSD)
- Experience in 1 or more of the following areas: Compression, Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower
- Capable of cleaning, setting-up, dismantling and operating state of the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12.
- Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
- Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
- Basic math, reading, legible writing skills, and problem-solving abilities.
- Proficient in sampling batches
- Ability to participate in Continuous Improvement projects.
