Charter Medical LLC
1st Shift Manufacturing Technician I (7am - 3pm)
Charter Medical LLC, Winston Salem, North Carolina, United States, 27103
Job Description
Job Description
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 Manufacturing Technician’s primary role is to work as a member of the production Line Team. In addition, this role provides mechanical troubleshooting, and performs changeovers, and repairs as needed. There are three (3) levels within this position. 1st Shift: Monday-Friday 7:00 am-3:00 pm Primary Responsibilities Supports production needs as required as an operator Manually assembles and packages components of a medical device. Labels and packages 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 Line Leads to maintain quality requirements. Operates equipment following safety guidelines. Reports any nonconformance Provides mechanical troubleshooting across manufacturing floor such as tooling alignment, Teflon changes, mandrel changes and repairs on equipment as needed Tests and documents result of completed production processes Performs machine changeovers per
specification/verifications
which includes proper documentation of machine settings as well proper tooling to support production 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. Assists in the training of new employees Performs other job-related responsibilities as assigned. Qualifications High School diploma or equivalent. 3 to 5 years’ experience in related field, or an equivalent combination of education and experience. Must be capable of completing assembly and test records for regulatory requirements. Ability to read schematics and technical drawings. Ability to perform complex test operations and operate and maintain test equipment. Ability to understand and follow the requirements of applicable work instructions and/or internal specifications. 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. Familiarity with an ERP system and Quality Management System (eQMS) preferred. Technical education preferred. Prior experience as an Engineering and/or Research Technician in a Manufacturing Environment (preferred). Must be able to work extended hours when required. 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test. Competencies Machine Operation:
Operate and supervise one or a group of machines for the manufacture, processing or packaging of products. Work Ethic:
Demonstrating and supporting the organization's ethics and values. Problem Solving:
Having the ability to identify problems and issues of varying complexities and to find effective solutions with few guidelines. Identifying problems and the solutions to them. Adaptability:
Adapting in order to work effectively in ambiguous or changing situations, and with diverse individuals and groups. Accepts change and adapts to a variety of assignments and/or situations while maintaining his/her efficiency. Champions change with a positive attitude. Personal Accountability:
Holding yourself and others to high standards of accountability, developing team's autonomy 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
Job Description
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 Manufacturing Technician’s primary role is to work as a member of the production Line Team. In addition, this role provides mechanical troubleshooting, and performs changeovers, and repairs as needed. There are three (3) levels within this position. 1st Shift: Monday-Friday 7:00 am-3:00 pm Primary Responsibilities Supports production needs as required as an operator Manually assembles and packages components of a medical device. Labels and packages 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 Line Leads to maintain quality requirements. Operates equipment following safety guidelines. Reports any nonconformance Provides mechanical troubleshooting across manufacturing floor such as tooling alignment, Teflon changes, mandrel changes and repairs on equipment as needed Tests and documents result of completed production processes Performs machine changeovers per
specification/verifications
which includes proper documentation of machine settings as well proper tooling to support production 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. Assists in the training of new employees Performs other job-related responsibilities as assigned. Qualifications High School diploma or equivalent. 3 to 5 years’ experience in related field, or an equivalent combination of education and experience. Must be capable of completing assembly and test records for regulatory requirements. Ability to read schematics and technical drawings. Ability to perform complex test operations and operate and maintain test equipment. Ability to understand and follow the requirements of applicable work instructions and/or internal specifications. 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. Familiarity with an ERP system and Quality Management System (eQMS) preferred. Technical education preferred. Prior experience as an Engineering and/or Research Technician in a Manufacturing Environment (preferred). Must be able to work extended hours when required. 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test. Competencies Machine Operation:
Operate and supervise one or a group of machines for the manufacture, processing or packaging of products. Work Ethic:
Demonstrating and supporting the organization's ethics and values. Problem Solving:
Having the ability to identify problems and issues of varying complexities and to find effective solutions with few guidelines. Identifying problems and the solutions to them. Adaptability:
Adapting in order to work effectively in ambiguous or changing situations, and with diverse individuals and groups. Accepts change and adapts to a variety of assignments and/or situations while maintaining his/her efficiency. Champions change with a positive attitude. Personal Accountability:
Holding yourself and others to high standards of accountability, developing team's autonomy 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