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Senior QA Specialist

1 month ago

Concord, United States Vakulatech Full time
Job DescriptionJob DescriptionPlease share your resumes at jobs@vakulatech.comJob Role: Senior QA SpecialistLocation: Concord, CAContarct: W2

RESPONSIBILITIES

  • Overseeing and ensuring timely completion of quality system deliverables, including non-conformance (NC) and corrective/preventive actions (CAPA), internal audit findings, supplier audits, and actions from management and data reviews.
  • Performing other related duties as required.
  • Managing and maintaining supplier documentation for production, release, and development activities.
  • Reviewing manufacturing, quality control (QC), and release records, as well as documentation for medical devices and drug substances/products.
  • Providing guidance on non-conformance situations and investigations, evaluate root causes and corrective actions, and ensure accurate and timely documentation closure.
  • Updating standard operating procedures (SOPs) and instructions (INSs), and creating flow charts and other quality documentation.
  • Publishing monthly reports on supplier qualifications, quality metrics, and key performance indicators (KPI) trends.

QUALIFICATIONS

  • Minimum 3 - 5 years of experience in the pharmaceutical or medical device industry.
  • Strong understanding of FDA Good Manufacturing Practices (GMP) regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards.
  • Excellent communication skills, including verbal, written, interpersonal, and listening abilities.
  • Strong organizational skills.

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