Job Description

Position Title: Production Operator II, III (Compression, Coating, Granulation, Encapsulation)

Job Code: Grade: (Compensation/HR Use Only)

Location: Chantilly, VA Department:

Production Operator II - III (Skilled Operators)- must have OSD Manufacturing experience

JOB SUMMARY

The Manufacturing/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.

Principle Accountabilities

Entry Level & Highly Skilled Pharmaceutical Production/Manufacturing Operators

Key Accountabilities:

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.

Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.

Cleans manufacturing equipment and facilities according to established SOPs.

Executes machine changeovers from batch to batch.

May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.

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

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