Quality Assurance Specialist

7 days ago

Gawler, Australia beBeeQuality Full time $95,000 - $110,000

Job Title: Quality Assurance Specialist

Job Summary:

This role is responsible for performing routine test procedures and supporting tasks within Quality Control to ensure timely generation of valid test results for controlled product manufacture.

Main Responsibilities:
  • Support the production of low bio-burden serum from blood harvested in sheep production facilities by analysing serum samples according to written, validated procedures.
  • Primary assays include bioburden, endotoxin, Biacore assays and polarisation fluroimmunoassay.
  • Involvement in Environment Monitoring Program for manufacturing areas within the serum production facility at Turretfield.
  • Monitor antibody production in sheep using appropriate assays.
  • Maintain a database of results and trend data as required.
  • Participate in development of new methods required for routine testing of low bioburden ovine serum, antibody and health monitoring of production flocks and qualification of new sheep for production status.
  • Assist in transfer of any new assays from external sources or from the BTG UK site.
  • Validate assays for routine testing.
  • Ensure all quarantined incoming goods are assessed for release against a written specification.
  • Write and review SOPs, work instructions, laboratory methods, specifications and AQR's as required to ensure procedures are documented and all documents are accurate and complete.
  • Ensure all equipment is calibrated and maintained in accordance with written procedures.
  • Draft calibration documents for new equipment as required.
  • Report, investigate and document out of specification results as per written procedures.
  • Document all incidents etc. as required and ensure corrective actions are completed in a timely manner.
  • Comply with relevant workplace health & safety legislation, codes of practice, standards, policies, operating procedures and work instructions, and be accountable for all EHS actions.

This description may be varied from time to time to reflect changing business requirements.

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