Senior QA Specialist

14 hours ago

Charlotte Bay, Australia beBeeQuality Full time $105,000 - $150,000
Quality Assurance Professional

The role of a Quality Assurance Auditor is crucial to maintaining the integrity of our quality systems and ensuring compliance with applicable regulations and internal standards. This position is responsible for managing internal and external audit programs, vendor qualifications, and corrective/preventive action initiatives.

  • Audit Management: Plan, schedule, and execute internal and external audits to assess compliance with regulatory requirements.
  • Audit of CMOs & Vendor Qualification: Conduct audits of contract manufacturing organizations (CMOs) and manage vendor qualification activities.
  • Third-Party Audits: Oversee third-party vendors responsible for international audits.
  • Documentation & QMS: Maintain the Approved Vendor List and all related documentation in the Quality Management System (QMS).
  • SCAR Program: Manage the Supplier Corrective Action Request (SCAR) program.
  • CAPAs & Risk: Assess audit findings for risk level and ensure timely and effective resolution of corrective and preventive actions (CAPAs).
  • Product Development & Investigations: Support product development, investigations, and CAPAs related to supplier and CMO operations.
  • Documentation & Metrics: Maintain thorough records of audits, vendors, and supplier documentation. Develop and implement systems to track performance and report departmental compliance metrics.

Required Skills and Qualifications

This role requires a minimum of 5 years of Quality Assurance auditing experience in a cGMP-compliant environment and 5 years of external vendor/supplier compliance auditing within an FDA-regulated industry. In-depth knowledge of applicable regulations, including 21 CFR Parts 210, 211, and 507 (Pharmaceuticals) and 21 CFR Part 111 (Dietary Supplements), is also essential.

Benefits

  • Competitive compensation package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

Other Responsibilities

Travel may be required up to 20-30% domestically, with occasional international travel possible.

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