2nd shift Line Leader I

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.