Job description

Who We Are:

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 Operator performs assembly, runs manufacturing lines, label printing functions, and/or packaging tasks in accordance with applicable Work Instructions (WI), Visual Inspection Criteria, Standard Operating Procedures (SOP), and internal specifications in a FDA regulated environment. There are four (4) levels within this position, defined by the Operator Career Ladder. The incumbent is assigned to workstations based on successful completion of training and may be primarily assigned to one area or functional task.

What You'll Do:

• Follows Standard Operating Procedures (SOP) and Work Instructions (WI’s) to manufacture and package components of medical devices.

• Performs assembly, machine operation, label printing, and packaging as required. May be cross trained in multiple areas or focus in a primary area.
• Performs responsibility in accordance with production standards and rates while adhering to quality requirements.
• Perform in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records. May require measuring and simple mathematical calculations to ensure product meets specification requirements.
• Labels and packages product as per internal specifications.
• Performs leak-testing and operates pouch sealing equipment according to product work instructions and company procedures.
• Participates in cross training and works at various stations to meet business needs.
• Maintains clean machinery, parts, and surrounding area.
• Completes all paperwork associated with daily tasks.
• Performs job requirements and operate equipment within safety guidelines and reports any nonconformance.
• May perform Inventory/cycle counts.

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.
• Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
• Ability to comprehend and follow SOP’s, WI’s, 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
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Evening shift
• Monday to Friday
• Night shift
• Overtime

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

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

Language:

• English (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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