QC Associate II

The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS sequencing, etc. The successful candidate must have a demonstrated capability of making data driven decisions in a high throughput environment to assure that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory, Customer, and Twist requirements. In this position you will report to the QC manager.

• →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.
• →Monitor QC data and assist in preparation of product and process quality reports, including trend analysis.
• →Author and review product quality documentation (SOPs, test methods, work instructions, labels).
• →Maintain QC batch records, calibration records, and inventory under ISO and GDP requirements.
• →Identify and support continuous improvement initiatives in the QC laboratory.

• 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/ISO
• Knowledge of molecular biology techniques such as PCR, Cloning & Sequencing
• Knowledge of analytical techniques such as spectroscopy, gel electrophoresis, etc.
• Experience with automated robotic systems and LIMS systems
• Proven ability to troubleshoot complex problems
• Excellent verbal and written communication skills