Production Operator

Arcera Life Sciences

The Production Operator is responsible for supporting daily manufacturing activities by operating equipment, handling materials, and ensuring products are produced according to quality and safety standards. The role involves monitoring machinery, carrying out routine checks, completing documentation, and following established procedures to maintain a smooth and efficient production flow. The Production Operator also collaborates with technicians and supervisors to troubleshoot issues and contributes to maintaining a clean, safe, and compliant work environment.

Key Responsibilities:

• Execute granulation, coating, and packaging operations as per SOPs, BMR/BPR, and cGMP guidelines.
• Set up, operate, clean, and maintain production equipment.
• Maintain hygiene and sanitation in manufacturing and packaging areas.
• Use appropriate Personal Protective Equipment (PPE) in designated areas.
• Report any deviations from procedures to supervisors or department heads.
• Calibrate balances and instruments as required.
• Ensure preventive maintenance and equipment qualification activities are completed on schedule.
• Perform line clearance and record temperature and relative humidity (RH) as per SOPs.
• Transfer and verify materials before batch processing.
• Conduct startup checks, challenge tests, and in-process quality checks.
• Perform AQL inspections and reconcile materials post-batch.
• Return excess materials to the warehouse and compile batch documentation for review.
• Manage equipment spare parts and adhere to production schedules.
• Support validation and qualification activities.
• Handle change parts and follow supervisor instructions.
• Continuously update knowledge on cGMP and regulatory guidelines.
• Dispose of in-process rejects and expired materials with proper documentation.
• Participate in audits and inspections to ensure compliance.
• Contribute to quality, safety, efficiency, and yield improvement initiatives.
• Follow Environment, Health, and Safety (EHS) policies and report any risks.