Location - Chestnut Ridge, NY
The Manufacturing Operator I 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. Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput and quality. Learns, understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate 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.
§ Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, 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.
§ Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.
§ Executes machine change-overs from batch to batch.
§ Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.
§ Learns sampling techniques.
§ Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward.
§ 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.
§ Learns to troubleshoot process issues with guidance. Refers deviations from standard procedure to the supervisor.
§ May participate in continuous improvement projects.
Safety & Compliance
§ 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.
Teamwork & Collaboration
§ Learns the responsibilities of being a team member.
§ Contributes to team and project success by sharing novel insights.
§ Collaborates typically within own cross-functional work unit.
§ HS diploma or equivalent at minimum, with 0-2 years’ related experience*