QC Lab Technician II – Precision Analytical Testing & QA

Regulatory Jobs; Mebane (NC); Presencial; USD 42.000 - 54.000; Jornada completa

Descripción de la vacante

Waters Corporation in North Carolina (Mebane) is seeking a Quality Control Lab Technician to perform visual and analytical testing of incoming, in-process and finished goods in a regulated environment. You will document results, support environmental monitoring, and participate in continuous improvement projects while maintaining 5S and proper waste handling.

The role requires at least 2 years in cGMP/GLP or medical device QA, proficiency with Excel and SAP, and the ability to work independently

Formación

• Minimum of 2 years’ experience in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device Quality Assurance role. (Associate’s degree in quality, science, or engineering related field may be equivalent to 2 years’ experience), with a minimum of 3 years related laboratory experience.
• Experience with sampling techniques, inspection standards, or use of analytical laboratory equipment.
• Experience working in an FDA regulated environment (medical device or pharmaceutical industry).
• Demonstrated understanding in the use of calibrated equipment and ability to follow equipment maintenance repair procedures.
• Experience with SAP.
• Excellent math skills and the ability to utilize Excel for basic calculations and graphing.
• Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
• Excellent observation skills with a bias for “corrective action” and improve work environment processes and procedures.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance.

Responsabilidades

• Perform visual and analytical testing on incoming, in-process and finished goods, stability samples and product returns for compliance with established quality specifications, including pH, density measurement, spectrophotometry, gas chromatography.
• Perform environmental monitoring for RODI water system and Liquid Media manufacturing.
• Accurately document test results on QC reports, Stability Test reports, Offline Test Requests Validations and First Article Inspections as applicable.
• Analyze data to specifications and designate as accept/reject.
• Work with manufacturing, receiving and materials personnel to complete required QC testing, documentation in a timely manner.
• Perform out-of-specification investigations, troubleshooting, and other duties.
• Prepare standards and control materials. Maintain documentation of preparation.
• Ensure that equipment is cleaned and maintained according to work instructions.
• Maintain inventory to ensure QC lab reagents and supplies are ordered.
• Participate in continuous improvement activities (e.g. kaizen).
• Handle hazardous waste as appropriate.
• Maintain 5S of Quality Labs and Stability Chamber area when used.
• Additional responsibilities as assigned by Quality management.

Conocimientos

Attention to detail

Excel proficiency

Math skills

English fluency

Independent worker

Teamwork

Decision making

Educación

High School Diploma/GED

Associate degree in quality/science/engineering

Herramientas

SAP

Excel

Minitab

Descripción del empleo

Waters Corporation in North Carolina (Mebane) is seeking a Quality Control Lab Technician to perform visual and analytical testing of incoming, in-process and finished goods in a regulated environment. You will document results, support environmental monitoring, and participate in continuous improvement projects while maintaining 5S and proper waste handling.

The role requires at least 2 years in cGMP/GLP or medical device QA, proficiency with Excel and SAP, and the ability to work independently