Job Description

Entry Level & Highly Skilled Pharmaceutical Production/Manufacturing Operators

The Manufacturing/Production Operator reports to the Production Manager and 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).

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.

Required Skills & Abilities:

• Proficient in running machinery.
• Proficient in (Master Clean/Surface clean) equipment cleaning.
• Proficient in sampling batches.
• Proficient in doing basic set-ups.
• Ability to participate in Continuous Improvement projects.
• Qualified in any of the following manufacturing processes:
• Weighing
• Blending
• Granulation
• Compression
• Coating
• Encapsulation
• Potent Compound

Experience & Education

• High School Diploma or equivalent experience
• Any production or retail store experience
• Knowledge of Good Manufacturing Practices (cGMP)
• Looking for Pharmaceutical Glatt, Compression and Pan coating experience

Level II Operator:

• High School diploma, GED or College Associate Degree
• Minimum of 2-5 years of pharmaceutical manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.
• Forklift certification may be required for certain jobs.
• Level III Operator: HS Diploma, GED or College Associate Degree
• Minimum of 5+ years of pharmaceutical manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.
• Forklift certification may be required for certain jobs.

Knowledge:

• Current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements
• Standard Operating Procedures for process rooms and manufacturing area
• GMP compliance in a regulated work environment
• Manufacturing processes and equipment procedures

Physical Requirements:

• Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

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