Job Description

- 2nd & 3rd shift- Multiple Openings

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.
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.

Documentation:

• Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
• Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
• Verifies the manufacturing process on BPR in an accurate and timely manner.
• Provides status updates and operational challenges on status boards.

Safety & Compliance:

• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participates in safety teams, start-up discussions, incident debriefing sessions, etc.
• Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
• Maintain a clean, organized, work area.

Required Skills & Abilities:
Often referred to as \xe2\x80\x9ccompetencies\xe2\x80\x9d, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• 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
• Wurster Coating
• Encapsulation

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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.

Job Type: Full-time
Requirements Minimum Education & Experience

• 
  Level II Operator:
• HS diploma, GED or College Associate Degree
• Minimum of 3-7 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 7+ 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:

• Strong background in solid dose manufacturing (OSD)
• Experience in Pharmaceutical Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower
• Capable of cleaning, setting-up 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.

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