at bioMerieux, Inc. in Lombard, Illinois, United States
Job Description
Compounding Operator 1
Location: Lombard, IL, United States
Position Type: Unfixed Term
Job Function: Manufacturing
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A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
Description
POSITION SUMMARY
The Compounding Operator position is responsible for the preparation and formulation of Prepared Culture Media plates, bottle, and tubes in a cGMP compliant manner.
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.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an... For full info follow application link.
