Quality Associate 2 (Biotech)

TL;DR

Quality Associate 2 (Biotech): Assist in implementation and management of Quality Management System for clinical laboratory operations with an accent on compliance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820, GCP, and GCLP. Focus on auditing clinical study data, reviewing production records, investigating nonconformances, and driving continuous improvement initiatives.

Fremont, CA. Onsite Tuesday - Saturday from 9:30am - 6pm.

$85,000 - $95,000 per year

Company

Transforming cancer management through personalized testing with highly sensitive assays for MRD detection, targeted therapies, and biomarker strategy.

What you will do

• Perform quality review and audits of clinical study data for GCP/GCLP compliance.
• Conduct incoming inspection and release of materials to support weekend operations.
• Review laboratory production records, batch history, equipment, and environmental monitoring.
• Prepare data audit reports and verify adherence to GCLP/GCP guidelines.
• Evaluate SOPs, initiate investigations for nonconformances, and maintain quality policies.
• Drive continuous improvement and assist in root cause analysis for CAPAs.

Requirements

• Bachelor's degree + 3-5 years in Quality role in medical device or biotech.
• Strong knowledge of ALCOA+ principles.
• Experience auditing lab data under GCLP and clinical data under GCP.
• Ability to compile data, summarize results, and author SOPs.
• Experience with quality methodologies (CAPA, Lean, 5 Whys, Pareto).
• Expert in Word, Excel, Google Suite, and electronic document systems.

Nice to have

• Experience in ISO Standards and FDA-regulated environments.

Culture & Benefits

• Competitive compensation with overtime, performance bonus, equity, and full benefits.
• Medical, dental, vision, 401(k) match, ESPP, tuition reimbursement.
• Sick/vacation time, commuter benefits, EV charging, onsite gym, wellness programs.