Cell and Gene Therapy
3rd shift Quality Control Technician I (Sunday-Thursday 11:00 pm-7:00 am)
Cell and Gene Therapy, Winston Salem, North Carolina, United States, 27104
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 Quality Control Technician conducts inspection and testing activities at various manufacturing stages including incoming, in-process, and final release.
3rd shift: Sunday-Thursday 11:00 pm-7:00 am
What you will do: Performs in-process and final inspections; including visual, dimensional and functional verifications, as well as inspections for defects, non-conformance and contamination with adherence to Work Instructions (WI's), Visual Inspection Criteria, Standard Operating Procedure (SOP) and internal specifications defined for each product. Records inspection results and completes appropriate documentation; assists notification of non-conforming product/processes. Follows documented procedures to maintain control of non-conforming products by identifying and segregating products that do not meet specifications and completing appropriate documentation. Performs Quality Control (QC) verification of line openings, closing and subsequent line clearances. Records sample collection in current Enterprise Resource Planning (ERP) system. Performs verification or calibration of measurement equipment. Ensures proper labeling of acceptable material. Reviews supplier certifications/packing list to ensure compliance with specification. Assists in collection of data for certification of finished products. Logs, files, and maintains finished goods retention samples. Assists with receiving inspection of raw materials using appropriate sampling plan and measuring/test equipment as needed. Assist in all areas within the quality department as needed. Who you are:
High school graduate or equivalent required. Two years Quality experience preferred. 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. 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 Bonuses 401k with excellent company match Health Insurance with multiple plans to choose form Paid Short Term and Long Term Disability
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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 Quality Control Technician conducts inspection and testing activities at various manufacturing stages including incoming, in-process, and final release.
3rd shift: Sunday-Thursday 11:00 pm-7:00 am
What you will do: Performs in-process and final inspections; including visual, dimensional and functional verifications, as well as inspections for defects, non-conformance and contamination with adherence to Work Instructions (WI's), Visual Inspection Criteria, Standard Operating Procedure (SOP) and internal specifications defined for each product. Records inspection results and completes appropriate documentation; assists notification of non-conforming product/processes. Follows documented procedures to maintain control of non-conforming products by identifying and segregating products that do not meet specifications and completing appropriate documentation. Performs Quality Control (QC) verification of line openings, closing and subsequent line clearances. Records sample collection in current Enterprise Resource Planning (ERP) system. Performs verification or calibration of measurement equipment. Ensures proper labeling of acceptable material. Reviews supplier certifications/packing list to ensure compliance with specification. Assists in collection of data for certification of finished products. Logs, files, and maintains finished goods retention samples. Assists with receiving inspection of raw materials using appropriate sampling plan and measuring/test equipment as needed. Assist in all areas within the quality department as needed. Who you are:
High school graduate or equivalent required. Two years Quality experience preferred. 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. 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 Bonuses 401k with excellent company match Health Insurance with multiple plans to choose form Paid Short Term and Long Term Disability
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.