Description

POSITION SUMMARY

• The individual will perform or assist in the setup, operation and cleaning of equipment used throughout the Prepared Culture Media formulation process.
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks.

The individual will also perform all ancillary tasks to support routine production, including area cleaning and 5S, movement of materials, weighing of raw materials, reworks, material reconciliation, and other tasks deemed necessary by production management.

PRIMARY DUTIES

Production

• Perform accurate calculations, weigh-outs, verifications and mixing of chemical compounds for product formulations by following batch record instructions.
• Set-up, operate and troubleshoot various types of kettles, scales, cleaning stations, Autoclaves and basic laboratory equipment (graduated cylinder, pH meter, pipette, etc.)
• Perform necessary calibrations and verifications of formulation and weigh-out equipment.
• Handle hazardous and non-hazardous raw materials to move them through the process flows in compliance with outlined procedures and safety standards.
• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs.
• Perform ancillary cleaning and sanitization activities of chemical containers, production equipment and areas.
• Communicate appropriately with maintenance and area leads to tackle issues.

Quality

• Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices.
• Perform and document all processes and procedures in a timely manner while maintaining compliance with all company and regulatory agency regulations.
• Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
• Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
• Maintain all work areas in a well-organized, clean, and tidy manner at all times in compliance with outlined 5S standards and cGMP requirements.

Safety

• Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training.
• Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

Other Duties

• Collect accurate data for reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
• Accurately interpret technical documentation with a high attention to detail.
• Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
• Perform other duties as assigned by Management.

STUDIES

High School Diploma or GED

EXPERIENCE

Minimum of 2 years in a regulated production/operations environment or Associates Degree

SKILLS

• Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Ability to rapidly learn new procedures and reduce them to practice.
• Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 90-day period of working with a trainer.