Job Description

Description:

The Production Operator III fulfills a critical role in daily execution of Pharmacy, Mixing, Compression and Coating manufacturing. Performs functions relating to the development and processing of drug products, ensuring product compliance to establish current Good manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs).Responsibilities include: reading and reviewing relevant sections in study protocols and amendments, and follow directions therein, assist in setting up calculation/verification data prior to study initiation, verify preparation of test materials prior to dose administration, prepare test article/substance dosage solution/suspension(s), perform procedures consistently and record outcomes correctly.The Production Operator III is an experienced level position with minimal direct supervision and oversight by assigned supervisor. This individual is expected to more independently plan and make decisions on defined projects and deadlines set by others and understanding and running processes to meet the assigned schedule.

Essential Functions:

• Performs commercial manufacturing operations for solid oral dosage forms, including granulation, blending, compression, and coating, in accordance with approved batch records, SOPs, cGMP requirements, and established manufacturing processes.
• Runs assigned manufacturing processes to meet established production schedules, quality standards, and operating requirements. Identifies and evaluates process issues or deviations, analyzes relevant data, and promptly communicates findings to the Supervisor.
• Able to independently perform all B-stage reconciliation activities accurately and in accordance with established SOPs, batch records, and cGMP requirements.
• Plans and prioritizes assigned activities and independently executes manufacturing processes to meet established production schedules and deadlines.
• Analyzes manufacturing process issues, supports troubleshooting activities, and effectively communicates findings, observations, and recommended actions to supervisors.
• Perform and accurately document in-process testing, including loss on drying (LOD), disintegration, bulk density, tablet hardness, thickness, friability, and weight testing, in accordance with established procedures and cGMP requirements.

Additional Responsibilities:

• Responsible for all applicable documentation, creating and maintaining activity records and requirements.
• Perform other job related duties as assigned.