Bio Pharmaceutical Quality Assurance Specialist

4 days ago

Brisbane, Queensland, Australia beBeeQualityControl Full time $140,000 - $160,000
Job Role Overview

This fixed term 12-month contract position is based at our Brisbane site, focusing on the manufacturing of bio-pharmaceutical products.

The quality control team in Brisbane supports client studies required for regulatory acceptance of drug substance and drug product. Responsibilities include:

  • Assuring timely accurate and scientifically sound output of data from stability studies.
  • CoA SoT generation for batch release shipment of test samples.
  • Coordinating and accepting results from external third party test facilities as required for each customer project.

We are seeking a highly motivated individual to join our team as an Engineer Scientist I Quality Control. The successful candidate will have a degree in Bio-Technology Chemistry or closely related field and at least 2 years industry experience in pharmaceutical or biotechnology industry aligned to Analytical and Quality Control fields.

Key Responsibilities:

  • Independently liaise with Clients and Project Managers regarding their Quality requirements for stability studies batch testing external shipments and external contract testing.
  • Collaborate with QC Labs QA Program Management Warehouse and Logistics 3rd party contract labs equipment maintenance vendors and contractors.
  • Generate shipping documentation and sample submission forms required for testing of Client samples at external facilities review and approve test reports supplied from external facilities.
  • Perform aseptic aliquoting of bulk samples typically from Operations department.
  • Support Quality Control laboratory teams as required to ensure relevant testing is performed on time and ensure accordance with Regulatory Guidelines in performance and guidelines for Client stability studies.
  • Knowledge of Change Control Deviations CAPA OOS and OOT Document Management related to the Quality Systems operating on the Brisbane site.
  • Practical application of various risk assessments tools i.e. failure mode effect analysis fishbone diagrams hazard and operability studies.
  • Engage with the Quality teams QA and QC to ensure batch release documentation and site delivery times are met in a profitable manner.
  • Support PPI activities for the business.
  • Ensure traceability and legibility of all QC documentation and ensure effective execution of documentation records for client requirements.
  • Support generation and approval of Work Flows and MLPs in gLIMS.
  • Work within EH S guidelines Corporate Quality Standards Standard Operating Procedures and data integrity maintain the Companies TGA and other manufacturing licenses.
  • Mentor and motivate members of the team by delivering training of QC staff as required.

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