Manufacturing Operator III - Granulation

Manufacturing Operator III – Granulation

The Manufacturing Operator III – Granulation 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.

Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. 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. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.

Responsible for the safe and efficient execution of job duties. May serve as back-up to the Senior Manufacturing Technician.

Manufacturing Operations work unit at the various Strides locations listed above

• Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, mixing, granulating, drying, milling, blending, potent compound, etc. Meets 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 s, 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 change-overs from batch to batch.
• Completes a variety of assignments independently based on established procedures.
• Identifies process improvements that drive increased efficiency, throughput and quality.
• May sample batches, including validation 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 debriefing sessions to understand the reasons why and what needs to be corrected moving forward.

• Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks and E-logs) 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.

• Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.
• Typically participates in Continuous Improvement projects of a higher scope and complexity.

• Carries out processing/manufacturing activities safely, as required, on a daily basis.
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participates in safety teams, start-up discussions, and incident debriefs, etc.
• Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
• Maintains a clean, organized work area.

• Conforms to all training requirements, including company required and machine specific training.
• May become a certified trainer and provide mentoring and training.

• Exhibits team work and motivates others to achieve project objectives.
• Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.

• HS diploma or equivalent at minimum, with 2-3 years' related experience*
• Forklift certification may be required for blending and granulation.

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Knowledge of cGMPs.
• Basic math, reading, legible writing skills, and problem solving abilities.
• Has thorough knowledge and skills in the processes noted below.
• Has a wide range of technical skills and operational knowledge.
• Understands the practical applications to problems and situations ordinarily encountered.

• Proficient in running machinery.
• Proficient in (Master Clean/Surface clean) equipment cleaning.
• Proficient in setting up machinery.
• Proficient in trouble shooting.
• Ability to become a certified trainer and provide certified training in one process.
• Ability to…