Quality Assurance Specialist

7 days ago

CanterburyBankstown Council, Australia beBeeQuality Full time $100,000 - $125,000
Job Title: Quality Assurance Professional

We are seeking an experienced professional to join our team as a Quality Assurance Associate.

This role is primarily responsible for supporting the management of quality systems ensuring continued compliance with regulations, guidelines and industry standards.

  • Creation, review and approval of controlled documentation - assist in development and implementation of quality systems including writing, and review, of procedures and work instructions and training
  • Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements
  • Preparation of product quality reviews
  • Investigation and management of non-conformances, CAPAs, deviations and complaints
  • Assistance with audit findings and audit management
  • Cross-functional support of design and manufacturing and including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etc
  • Conduct of other routine QA duties such as issue and review of batch documentation, incoming and finished goods release
  • Plan and execute assigned process improvement projects
Required Skills and Qualifications:
  1. University degree in Science, Engineering or equivalent
  2. At least four years' experience in GMP within Pharmaceuticals, Medical Devices or related field
  3. At least two years' experience in a QA role
  4. High level of verbal and written communication and numeracy skills
  5. Thorough knowledge of standards and governing bodies
  6. Excellent problem-solving skills
  7. Proficient attention to detail, excellent written and verbal communication skills
  8. Ability to work as part of a team
Benefits:
  • Rare opportunity to join a company that manufactures both drug and medical device with exposure to FDA, TGA and European Notified Bodies
  • Competitive salary package
  • Professional development opportunities
  • Health and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membership
  • Be part of an inspired and talented leadership team
  • Company culture that values respect, collaboration, innovation and ethics

You will be joining an organisation that embraces diversity & inclusion.

We are committed to providing products, services and solutions that improve clinical outcomes every day. If you feel the same – we would welcome your application.

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