QA Operations Specialist II
$60,000–$70,000 year
On-siteSan Diego, California, United States
Job Summary
Review and approve quality events, deviations, NCRs, CAPAs, and change controls to ensure timely investigations and appropriate documentation. Conduct quality investigations using root cause analysis tools like 5-Whys and FMEA to assess corrections and monitor effectiveness. Provide oversight for the quality operations training program and lead cross-functional teams in risk identification and mitigation activities. Maintain control of documents and records while assuring compliance with ISO standards, GDP practices, and customer specifications. Participate in internal and external audits, review stability protocols, and manage document change orders with manufacturing and R&D teams to continuously improve quality operations.
Required Qualifications
- Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
- Quality professional with a minimum of 5 years relevant experience in a life science industry
- Requires knowledge of ISO 9001 standards (or ISO 13485)
- Strong and effective verbal and written communication skills
- Strong interpersonal, teamwork, and customer interfacing skills
- Strong problem-solving skills and analytical skills applied to investigations
- Self-motivated and able to organize and prioritize multiple tasks
- Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization
- Proficient in Microsoft Office
Desired Qualifications
- Experience with NetSuite ERP and MasterControl is a plus
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