QA Operations Specialist II
$60,000–$70,000 year
On-siteSan Diego, California, United States
Job Summary
Review and approve quality events including deviations, NCRs, CAPAs, and complaints to ensure timely investigations. Manage change controls for materials, equipment, and procedures while overseeing document and record control functions. Conduct quality investigations to assess root causes, corrections, and preventive actions using tools like 5-Whys and DMAIC. Provide oversight for training programs and lead cross-functional teams in risk identification and mitigation activities. Compile and report quality metrics to ensure visibility of the Quality Management System health. Participate in internal and external audits and work with various functions to continuously improve quality standards.
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
- #LI-Onsite
Desired Qualifications
- Experience with NetSuite ERP and MasterControl is a plus
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