1st shift Operator I (Monday-Friday 7:00 am-3:00 pm)

Polyzen•Winston-Salem, NC

13d

About The Position

Charter Medical, part of the Solesis family of companies, provides single-use solutions for life sciences innovators. The Operator performs assembly, operates manufacturing lines, prints labels, and packages products according to applicable Work Instructions, Visual Inspection Criteria, Standard Operating Procedures, and internal specifications in an FDA-regulated environment. The position has four levels defined by the Operator Career Ladder. Workstations are assigned based on completed training, and the operator may focus on one area or task or be cross-trained in multiple areas. This is a first-shift position, Monday through Friday, from 7:00 a.m. to 3:00 p.m.

Requirements

High school graduate or equivalent.
Effectively communicate with coworkers and management; business communication is conducted in English.
Comprehend and follow English-language SOPs, Work Instructions, and safety, quality, and HR policies and procedures.
Basic mathematics skills, including addition, subtraction, multiplication, and division using whole numbers, common fractions, and decimals.
Basic computer skills, including the ability to use MS Outlook and automated manufacturing and quality systems.
Excellent interpersonal skills and ability to work well with others in a team environment.
Ability to complete paperwork according to work instructions, standards, and other specifications.
Dependability and reliability.
Willingness to accept change, learn, and work with new processes.
Ability to work extended hours when required.
20/20 vision, with corrective eyeglasses if needed, and ability to pass a color-perception test.

Nice To Haves

Basic understanding of Good Manufacturing Practices (GMP) and experience working in FDA-regulated industries.
Familiarity with an ERP system and electronic Quality Management System (eQMS).

Responsibilities

Follow Standard Operating Procedures and Work Instructions to manufacture and package medical-device components.
Perform assembly, machine operation, label printing, and packaging as required; work in a primary area or across multiple areas after cross-training.
Meet production standards and rates while adhering to quality requirements.
Conduct in-process inspections and tests, document and report defects in production records, and escalate issues to management.
Measure products and perform simple calculations as needed to confirm they meet specifications.
Label and package products according to internal specifications.
Perform leak testing and operate pouch-sealing equipment according to product work instructions and company procedures.
Maintain clean machinery, parts, and the surrounding work area.
Complete paperwork associated with daily tasks, operate equipment within safety guidelines, and report nonconformance.
Perform inventory or cycle counts as needed.