QC Associate II

What You’ll Be Doing

• Independently perform QC release for standard product families to ensure 100% compliance with customer specifications.
• Execute and troubleshoot routine QC assays (NGS, qPCR, fragment analysis, NanoDrop/Qubit); identify and escalate atypical results.
• Initiate Nonconformances and other Quality Events for OOS, OOT, and atypical results, and follow up on progress and action items.
• Support impact assessments and investigations; contribute to root cause analysis using 5-Why, Fishbone, and DMAIC techniques.
• Review CAPAs and process deviations from a QC perspective.
• Maintain QC batch records, calibration records, and inventory under ISO and GDP requirements.
• Identify and support continuous improvement initiatives in the QC laboratory.

What You’ll Bring To The Team

• BS/MS in Biochemistry, Chemistry, Molecular Biology or related field
• 2+ years industrial experience in Operations/QC
• Preferred Qualifications: Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISOKnowledge of molecular biology techniques such as PCR, Cloning & SequencingKnowledge of analytical techniques such as spectroscopy, gel electrophoresis, etc.Experience with automated robotic systems and LIMS systemsProven ability to troubleshoot complex problemsExcellent verbal and written communication skills