Senior Quality Assurance Specialist

22 hours ago

Concord, California, United States a BiotechnologyMedical Equipment manufacturer in Concord, CATX Full time
Job Summary

We are seeking a highly skilled Senior QA Specialist to join our team at a Biotechnology/Medical Equipment manufacturer in Concord, CATX. The successful candidate will be responsible for overseeing and ensuring timely completion of quality system deliverables, including non-conformance and corrective/preventive actions, internal audit findings, supplier audits, and actions from management and data reviews.

Key Responsibilities
  • Quality System Management: Oversee and ensure timely completion of quality system deliverables, including non-conformance and corrective/preventive actions, internal audit findings, supplier audits, and actions from management and data reviews.
  • Supplier Management: Manage and maintain supplier documentation for production, release, and development activities.
  • Quality Control: Review manufacturing, quality control, and release records, as well as documentation for medical devices and drug substances/products.
  • Investigation and Resolution: Provide guidance on non-conformance situations and investigations, evaluate root causes and corrective actions, and ensure accurate and timely documentation closure.
  • Process Improvement: Update standard operating procedures (SOPs) and instructions (INSs), and create flow charts and other quality documentation.
  • Reporting and Analysis: Publish monthly reports on supplier qualifications, quality metrics, and key performance indicators (KPI) trends.
Requirements
  • Experience: Minimum 3 - 5 years of experience in the pharmaceutical or medical device industry.
  • Knowledge: Strong understanding of FDA Good Manufacturing Practices (GMP) regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards.
  • Skills: Excellent communication skills, including verbal, written, interpersonal, and listening abilities. High attention to detail and accuracy. Ability to exercise independent judgment. Strong organizational skills. Effective time management skills, including scheduling, timeline management, and task prioritization.
  • Education: Bachelor's degree in a scientific discipline.

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