Production Operator

Production Operator - 1st ShiftPosition Summary: Must be familiar with manufacturing packaging.6am - 4:30pm shift (Monday - Thursday). Candidates must be available for overtime.Responsibilities:Production:Set-up, operate, and troubleshoot various production machines for filling and high-speed packaging of Prepared Culture Media using HMI/SCADA interfaces.Operate a manufacturing process within controlled cleanrooms while meeting guidelines for production process flow.Perform equipment and component preparation tasks in non-controlled areas to meet batch processing timelines.Perform necessary calibrations and verifications of filling and packaging equipment.Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.Perform ancillary cleaning and sanitization activities of production equipment and areas.Quality:Ensure accurate completion of batch documentation in accordance with Good Documentation Practices.Perform in-process and AQL inspections to meet batch quality requirements.Provide assistance with the review and revision of Manufacturing Directions and SOPs.Assist with manufacturing deviation analysis, CAPA actions, and other process equipment related quality concerns.Safety:Comply with all OSHA and plant-specific safety policies and procedures.Appropriately use PPE (Personal Protection Equipment) as required.Other Duties:Collect accurate data for reports, charts, and KPI's.Accurately interpret technical documentation with high attention to detail.Assist with executing validation protocols associated with packaging equipment.Perform other duties as assigned by Management.Qualifications:High School Diploma or equivalent.Minimum of 2 years in a regulated production/operations environment.Demonstrated proficiency in the operation of high-speed, highly automated, production equipment.Knowledge of FDA and/or GMP regulations within a production environment.Ability to rapidly learn new procedures and reduce them to practice.Skills and Attributes:Knowledge of good Manufacturing practices (GMP).Ability to focus and follow written and oral directions.Good written and verbal skills.Solid math skills; understanding of mathematical conversions.Good mechanical aptitude and skills.