Quality Control Associate

Role Summary

Quality Control Associate responsible for supporting all product release testing activities from raw material to finished goods and product stability in compliance with ISO 13485 GMP requirements.

Responsibilities

• Perform analytical/functional testing for in-process and finish goods on manufactured products
• Perform analytical/functional testing on incoming raw materials
• Perform stability product testing to extend product dating
• Perform slide imaging and scanning for functional assay
• Review data and assess against established acceptance criteria
• Record, track, and maintain QC data in logs and spreadsheets
• Prepare QC reference standards, controls stocks, and cultures per established procedures
• Initial nonconformance/deviation

Qualifications

• B.S./B.A. in molecular biology, biochemistry, cell biology or related field with 1+ years of relevant laboratory experience; OR
• Associates degree in molecular biology, biochemistry, cell biology or related field, with 2+ years of relevant laboratory experience

Skills

• Experience in molecular biology techniques, microscopy and imaging
• Detail oriented, organized, and efficient
• Strong team player with the ability to work independently
• Excellent written and verbal communication skills
• Experience working in a Quality Control environment preferred
• Experience using Leica BOND III, BOND Rx, and Roche Ventana Ultra is a plus
• Experience using slide imaging scanners is a plus
• Experience in ISO 13485 and GMP environment a plus

Education

• As provided in Qualifications

Additional Requirements

• Significant amount of time in the QC laboratory
• Significant amount of time in the office setting analyzing results and finishing batch records
• Standing and walking; lifting and moving materials up to 50 pounds; use of hands for precise tasks such as handling samples and testing equipment