Manufacturing / QC Technician

Engineering Resource Group; Princeton (NJ); On-site; USD 65,000 - 80,000; Full time

Job summary

Engineering Resource Group is seeking a Manufacturing QC Technician to support Princeton, NJ production of surface-treated medical device components. You will apply multi-step wet chemistry, maintain aseptic technique, and follow SOPs and EHS guidelines.

You will perform in-process and final QC testing, interpret results, document deviations, and prepare data summaries. Proficiency with Excel and basic Minitab is preferred; FTIR/chromatography experience is a plus.

Qualifications

• Associate degree in Chemistry, Biology or related science preferred.
• Minimum 2 years of laboratory experience.
• Experience in a GMP or controlled manufacturing environment.
• Hands-on experience with wet chemistry and aseptic technique.
• Working knowledge of ISO quality standards and FDA 21 CFR regulations.
• Proficiency with Excel and 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.

Responsibilities

• Perform in-process and final QC testing of surface-treated components.
• Apply multi-step wet chemistry processes to modify device surfaces aseptically.
• Record results in batch records and elevate deviations.
• Analyze test data and prepare summary reports.
• Coordinate equipment calibration and preventive maintenance with outside vendors.
• Maintain inventory of reagents and consumables; place orders.
• Ensure compliance with GMP, ISO standards and FDA 21 CFR regulations.
• Support process control and continuous improvement with R&D/science teams.

Skills

Wet chemistry

Aseptic technique

Data analysis

Lab notebooks

Batch documentation

Education

Associate degree in Chemistry/Biology or related science

Tools

Excel

Minitab

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.