Manufacturing Associate

The Manufacturing Associate (Production Operator) is responsible for operating pharmaceutical production equipment and performing a wide range of manufacturing activities to produce drug products in compliance with current Good Manufacturing Practices (cGMP), customer requirements, and Standard Operating Procedures (SOPs). This role follows established procedures to complete tasks that may vary in scope and complexity, applies technical skills to recognize issues, and actively contributes to improving efficiency, throughput, and product quality.

The Manufacturing Associate runs processes to meet defined standards and production schedules, participates in debriefs when targets are not met, assists in troubleshooting process issues, and ensures all work is executed safely and accurately.

• Operate pharmaceutical production machinery in accordance with SOPs, including weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, compressing, encapsulating, and coating, including work with potent compounds.

• Follow written SOPs and cGMP guidelines to ensure the purity and quality of materials throughout the manufacturing process.

• Use all scales correctly, including performing printouts, zeroing, setting tares, and conducting daily calibration verification as required by SOPs.

• Examine Product s, Quality Control release tags, and Batch Production Records to verify that issued and staged raw materials are approved and suitable for production.

• Clean manufacturing equipment, production areas, and related facilities according to established SOPs to maintain a controlled and compliant environment.

• Execute machine changeovers between batches, ensuring proper setup, cleaning, and configuration for the next production run.

• Sample batches for quality testing when required and perform in-process product quality checks, documenting results accurately and promptly.

• Run manufacturing processes to meet assigned schedules, standards, and routers, and participate in debriefs to analyze and correct issues when targets are not achieved.

• Complete all documentation associated with manufacturing processes, including batch records, protocols, and logbooks, with a high level of detail, accuracy, and legibility.

• Meet documentation requirements for all applicable Batch Production pages, ensuring completion and attachment of dispensary and weight verification tickets.

• Verify manufacturing process steps on Batch Production Records (BPR) in an accurate and timely manner to support product traceability and compliance.

• Provide status updates on production progress and operational challenges using status boards and other communication tools.

• Assist in troubleshooting process and equipment issues to support continuous improvement and minimize downtime.

• Perform visual inspections of equipment, materials, and product as part of general production and quality control activities.

• Adhere to all safety procedures and guidelines to ensure safe and efficient execution of job duties in a GMP cleanroom environment.

• Hands-on experience with production and general manufacturing operations in a regulated environment.

• Ability to operate pharmaceutical production machinery, including equipment used for weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, compressing, encapsulating, and coating.

• Knowledge of and adherence to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).

• Proficiency in using measuring equipment and scales, including zeroing, setting tares, and performing daily calibration verification.

• Capability to work in a cleanroom and GMP facility while following all required…