Senior QA Specialist, GMP

2 months ago

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

QA Associate, Supplier (Contract)


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.
  • 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.
  • Performing other related duties as required.


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.
  • 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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