Manufacturing / QC Technician

Engineering Resource Group; Princeton (NJ); On-site; USD 60,000 - 75,000; Full time

Job summary

Engineering Resource Group is seeking a Manufacturing/ QC Technician to support surface-treated medical device components in Princeton, NJ. You will apply multi-step wet chemistry, aseptic techniques, and document results per SOPs and EHS rules.

The role includes in-process/final QC testing using FTIR and chromatography, data analysis with Minitab, and maintaining batch records and equipment calibration, with a focus on quality and process improvement.

Qualifications

• Proficiency with Excel and statistical software for data analysis.
• Hands-on wet chemistry and aseptic technique in a GMP/controlled environment.
• Familiarity with ISO quality standards and FDA 21 CFR regulations.

Responsibilities

• Apply multi-step wet chemistry processes to modify device surfaces using aseptic technique, per SOPs, work instructions and EHS guidelines.
• Perform in-process and final QC testing, including surface efficacy assays using FTIR, chromatography and related analytical instrumentation.
• Record and interpret results in production batch records; document and elevate deviations.
• Analyze test data using statistical methods and prepare summary reports.
• Support process control and continuous improvement efforts alongside R&D, biology and microbiology scientists.
• Maintain inventory of reagents, raw materials and consumables, including ordering from suppliers.
• Coordinate equipment calibration and preventive maintenance with outside service vendors; handle hazardous waste disposal per EHS requirements.
• Ability to maintain accurate, organized lab notebooks and batch documentation.

Skills

Excel

Minitab

Wet chemistry

Aseptic technique

Documentation

Statistical analysis

Laboratory safety

Education

Associate degree in Chemistry, Biology or related science

Tools

FTIR

Chromatography

Job description

• Permanent position for a Manufacturing/ QC Technician supporting production of surface-treated medical device components.
• Apply multi-step wet chemistry processes to modify device surfaces using aseptic technique, per SOPs, work instructions and EHS guidelines.
• Perform in-process and final QC testing, including surface efficacy assays using FTIR, chromatography and related analytical instrumentation.
• Record and interpret results in production batch records; document and elevate deviations.
• Analyze test data using statistical methods and prepare summary reports.
• Support process control and continuous improvement efforts alongside R&D, biology and microbiology scientists.
• Maintain inventory of reagents, raw materials and consumables, including ordering from suppliers.
• Coordinate equipment calibration and preventive maintenance with outside service vendors; handle hazardous waste disposal per EHS requirements.
• Associate degree in Chemistry, Biology or related science preferred.
• Minimum 2 years of laboratory experience.
• Experience in a GMP or controlled manufacturing environment, with basic QC training.
• Hands-on experience with wet chemistry and aseptic technique.
• Working knowledge of ISO quality standards and FDA 21 CFR regulations.
• Proficiency with Excel and statistical software such as Minitab for data analysis.
• Ability to maintain accurate, organized lab notebooks and batch documentation.
• Able to stand for extended periods, lift up to 25 lbs and work with hazardous chemicals (respirator provided).
• Experience with FTIR and/or chromatography a plus.