What are the responsibilities and job description for the 3rd shift Line Leader I (Sunday-Thursday 11:00 pm-7:00 am) position at Charter Medical?
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.
3rd Shift: Sunday-Thursday 11:00 pm-7:00 am
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.
Perks / Benefits:
- Generous Paid Time Off
- Paid Breaks
- Annual Bonuses
- 401k with excellent company match
- Health Insurance with multiple plans to choose form
- Paid Short Term and Long Term Disability
