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Form of workCharter Medical, LLC is a life sciences company that is committed to designing, developing, and manufacturing quality products to support cell and gene therapy, bioprocessing, and blood management.
The Production Operator works as part of the manufacturing line assembling medical device components, performing label printing and packaging functions, and operating machinery, in a FDA regulated production environment.
This is a 2nd Shift position, Monday-Friday 3:00pm -11:00pm.
Primary responsibilities include:
- Follows Standard Operating Procedures (SOPs) and Work Instructions to manufacture and package components of medical devices.
- Perform assembly, machine operation, label printing, and packaging as required. May be cross-trained in multiple areas, or focus in a primary area.
- Performs in accordance with production standards and rates while adhering to quality requirements.
- Conducts in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records.
- May require measuring and simple mathematical calculations to ensure product meets specification requirements.
- Performs leak-testing and operates pouch-sealing equipment.
- Maintains clean machinery, parts, and surrounding area
- Completes all paperwork associated with daily tasks.
Other Duties:
- Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
- Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
- Follows gowning procedures in designated areas.
- Follows established safety requirements and adheres to the Health Safety and Environment Management System.
- Performs other job-related responsibilities as assigned.
Qualifications:
- High school graduate or equivalent.
- Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
- Ability to comprehend and follow SOP’s, WI’s, policies, and procedures such a safety, quality, and HR that are written in English.
- Possess basic mathematical skills to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Basic understanding of Good Manufacturing Practices (GMP) and working within FDA regulated industries preferred.
- Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems.
