About this role
Who we are
Charter Medical, part of the Solesis family of companies, specializes in single-use solutions that enable life sciences innovators to turn bold ideas into lasting breakthroughs, supporting industry-leading companies in bringing life-saving therapies to market. Operating in North Carolina, Charter Medical employs more than 150 team members across two facilities in Winston-Salem.
Guided by a commitment to quality, innovation and customer success, Charter partners with customers to transform promising therapies into commercial realities. Employees contribute to solutions that support life-changing treatments and make a meaningful impact on patients around the world.
What we are looking for
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.
1st Shift: Monday-Friday 7:00 am-3:00 pm
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.
- Minimum 1 year of previous leadership experience preferred.
- 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.
- 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test.
Perks / Benefits
- Generous Paid Time Off
- Paid Breaks
- Annual Bonus
- 401(k) with excellent company match
- Health Insurance with multiple plans to choose from
- Paid Short Term and Long Term Disability