Job Description
Responsibilities:
· The Bio-manufacturing Cleanroom Operator is responsible for performing Manufacturing operations according to standard operating procedures and batch instructions.
· Responsibilities include training on cGMP manufacturing operations, operation and monitoring of cell culture and/or purification equipment, writing and reviewing cGMP documentation.
Key responsibilities / essential functions:
· Demonstrate effective written and verbal communication skills.
· Reads and follows standard operating procedures and master production records or receives verbal instructions regarding duties to be performed.
· Review completed cGMP documentation for accuracy.
· Routinely originate and revise standard operating procedures, master production records and solution preparation records.
· Assist in the set up and preparation of equipment and production runs.
· Operates Cell Culture and/or Purification production equipment in a cleanroom environment.
· Operates general manufacturing equipment to formulate buffers and Media.
· Works with team lead, engineers, supervisors, and managers to improve quality and process efficiency.
· Handle and deliver products and hazardous materials in compliance with all regulations and Company Policies.
· Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management.
· Complies with all EHS and Quality policies and procedures.
· Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures.
· Perform other duties as assigned.
Quality Specific Goals:
· Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
· Complete all planned Quality & Compliance training within the defined deadlines.
· Identify and report any quality or compliance concerns and take immediate corrective action as required.
· Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements.
· Throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability
· Provide evaluation, constructive feedback and leadership in the development of internal and external engineering, manufacturing, or service documentation
· Drive cross-department process improvements focused on reducing overall product cycle time.
· Develop and execute training plans as required Provide strong individual contributions in the context of achieving team goals.
· Provide technical leadership by assisting others in troubleshooting, answering questions and seeking engineering assistance
· Train other team members through technical communications and/or presentations Lead compliance and quality activities by looking for defect trends, learning about quality issues and concessions and passing information to other technicians.
· Serve as the manufacturing expert on new product introductions by providing feedback to engineering and manufacturing personnel as new products are developed and new procedures are implemented.
· Lead EHS projects/activities designed to eliminate hazards and improve overall safety of job operations
· Fill in as a Lead Technician as required by directing the work team, making task assignments and completing daily reports
· May participate in quality control inspections of certain subassemblies and final product Comply with EHS regulations and policies