1st shift Line Leader I (Monday-Friday 7:00 am-3:00 pm)

Job Description

Job Description

Who we are:

Charter 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.

About the role:

The Line Leader operates and monitors production on a designated line, ensuring the production folder is complete. There are three (3) levels within this position, defined by the Line Leader Career Ladder.

2nd Shift: Monday - Friday 3:00 pm-11:00pm

What you will do:

• Retrieves, stages, and verifies raw materials for use on production line.
• Completes associated paperwork, sets up line, gathers materials, and establishes rotations for their team.
• Reads and interprets production schedule. Provide direction to team to fulfill orders.
• Review and close out manufacturing portion of production folders, taking care to correct or note any discrepancies found.
• Accurate reporting in Enterprise Resource Planning (ERP) system of all raw materials consumed on production line.
• Documents details in the device history record related to non-conforming product.
• Stops non-conforming materials and places them on hold, coordinating with quality and production supervision to ensure proper storage of non-conforming product as required.
• Reports all downtime and waste.
• Calculates and meets hourly production rates.
• Elevates issues to appropriate Manager, Supervisor or Group Lead.
• Performs cycle counts and assists in annual inventory.
• Trains operators on assigned lines and completes proper documentation of proficiency.
• Demonstrates leadership capabilities.
• Assembles and packages components of a medical device per specifications.
• Performs in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records. Requires measuring and simple mathematical calculations to ensure product meets specification requirements.
• Participates in cross training and works at various stations to meet business needs.
• Operates and runs equipment, producing products used in the medical device industry.
• Maintains clean machinery, parts, and surrounding area.
• Completes all associated paperwork & ERP tasks, coordinating with team to maintain quality requirements.
• Operates equipment following safety guidelines.

Who you are:

• High school graduate or equivalent required.
• Minimum 2 years manufacturing experience preferred.
• Ability to effectively communicate with coworkers and management. Business communications is conducted in English.
• Ability to comprehend and follow SOP’s, WI’s, and 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 GMP and working within FDA regulated industries preferred.
• Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems.
• Excellent interpersonal skills with ability to get along well with others and work in a team environment.
• Ability to properly complete paperwork as required according to work instructions, standards, or other specifications.
• Excellent dependability and reliability.
• Meticulous attention to detail.
• Willingness to accept change, learn, and work with new processes.
• Familiarity with an ERP system and Quality Management System (eQMS) preferred.
• Must be able to work extended hours when required.

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