Job description

About us

As a life sciences company, Charter Medical, LLC, has supported the development of advanced immunotherapies for over 30 years. The integration of our single-use solutions in all six FDA-approved immunotherapies on the market today, has helped improve the lives of patients globally. Our passionate team is committed to designing and developing quality products that support rapid growth in cell and gene therapy, bioprocessing, and blood management. Put your skills, perspectives, and experiences into action by joining Charter Medical’s growing business and vibrant culture.

What We're 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.

What You'll 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.

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.

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Ability to stand frequently
• Ability to sit often
• Ability walk and/or move around in a controlled environment occasionally
• Ability to use hands to grasp and perform fine manipulation frequently
• Ability to stretch/reach with hands and arms frequently
• Ability to lift arms overheard occasionally
• Ability to climb or balance occasionally
• Ability to stoop, kneel, crouch, or crawl occasionally
• Ability to talk or hear frequently
• Ability to lift up to 50lbs often
• Ability to push and/or pull occasionally
• Ability to handle chemicals and/or lab work often

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.

Why Join Us!

We promote a collaborative, high energy and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.

This position includes a compensation package that includes a base salary plus a quarterly bonus based on company performance. We offer a comprehensive benefits package including medical insurance with Rx, vision insurance, dental insurance, life insurance, 401(k) and employer matched contributions, paid holidays and paid time off.

Charter Medical is a drug-free workplace. All offers of employment are contingent on passing a drug screen as well as a background investigation (including a criminal courts history, driving record report if applicable, and social security name and number verification). The company provides reasonable accommodations for disabilities.

Charter Medical participates in E-Verify as appropriate in accordance with company guidelines and federal or state law. This includes providing the Social Security Administration and, if necessary, the Department of Homeland Security, with information from each new employee’s Form I-9 to confirm work authorization.

Charter Medical is an Equal Opportunity Employer. We maintain a commitment to providing equal access to employment. We value diversity and encourage applications from all genders, members of minority groups, LGBTQ individuals, veterans, and disabled individuals.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Winston-Salem, NC 27103: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.