Senior Quality Assurance Specialist

7 days ago

Brisbane, Queensland, Australia beBeeAnalytical Full time $90,000 - $120,000
Key Quality Control Professional Position

We are seeking a skilled quality control professional to join our team in Brisbane.

The ideal candidate will have a strong background in analytical and quality control fields, with experience in test method development, qualification, and validation. They must be knowledgeable in cGMP practices and quality management systems (QMS), including experience with deviations, CAPA, OOS, OOT, document management, and change control.

Responsibilities
  • Ensure the quality and accuracy of test results.
  • Collaborate with other departments to drive process improvements.
  • Liaise with clients and project managers to meet quality requirements.
  • Generate shipping documentation and sample submission forms.
  • Perform aseptic aliquoting of bulk samples.
  • Support quality control laboratory teams.
  • Knowledge of change control, deviations, CAPA, OOS, and OOT.
  • Practical application of risk assessments tools.
  • Engage with quality teams to ensure batch release documentation and site delivery times are met.
  • Supporting PPI activities for the business.
  • Ensuring traceability and legibility of all QC documentation.
  • Supporting generation and approval of work flows and MLPs in gLIMS.
Requirements
  • Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
  • At least 2 years' industry work experience in the pharmaceutical or biotechnology industry aligned to Analytical and Quality Control fields.
  • Knowledgeable with test method development, qualification, validation.
  • Must be knowledgeable in cGMP practices and quality management systems (QMS) including experience with deviations, CAPA, OOS, OOT, document management, change control etc.
  • Enjoy working in a highly fast-paced and frequently changing environment with a wide variety of people and perspectives.
  • Experience in stability studies suitable for the bio-pharmaceutical industry.
  • Good attention to detail as a team member and when working independently.
  • Can communicate in multiple modalities (e.g. electronic, written, verbal, etc.).
  • Ability to prioritize multiple client programs and reports simultaneously.
  • Understanding of Microsoft applications (e.g. Excel, Word, Outlook).
  • Ability to use Smartsheets.
  • Knowledge of LIMs Sample Manager.
  • Adaptability: Ability to adapt to every day business requirements.
  • Collaborating: Work constructively with all departments and colleagues of multicultural backgrounds.
  • Continuous Improvement: Challenge current systems to drive process improvements.
  • Customer Requirements: Always deliver on promises made to customers.
  • Initiating Action: Work independently, and also show initiative in planned work. Ability to work on multiple projects or tasks simultaneously.
  • Handling Relations: Demonstrates the ability to support customer demands within business requirements and agreed timelines.
  • Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken.

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