Quality Assurance Specialist
2 weeks ago
At KE Select, we are partnering with a leading global organisation to appoint a Quality Scientist in Brisbane.
This is an exciting opportunity for someone to join our client's team and contribute to their commercial and clinical manufacturing operations in the Pharmaceutical, Biotechnology, and Life Science sectors.
The successful candidate will report to the quality leader and be responsible for ensuring that technical transfer and validation processes are completed according to quality and regulatory requirements.
This role involves customer interaction, source of support for QC equipment ensuring compliance, and management of control activities.
About the Role:- Client management on specific projects, managing expectations, and challenges
- Preparation of batch documentation/data, review protocols, and reports
- Investigate and evaluate new methods/techniques and manage control activities
- Liaise with internal stakeholders, specifically QC laboratory teams issuing relevant test methods for routine use
- Author analytical method transfer, feasibility, qualification, and validation protocols and reports in line with internal policies and regulatory guidelines
- Practical application of the Quality System, Change Control, Deviations, CAPAs, and Document Management related to the Quality Control Department
- Bachelor of Science (Chemistry, Biochemistry, Biotechnology)
- Knowledgeable in GMP, NATA, and cGMP
- Ability to work in a highly dynamic environment with diverse people and perspectives
- Proven record of ability to work as a team member and independently as required
- Effective communication skills in multiple modalities (e.g. electronic, written, verbal, etc.)
- Knowledge of working with test method development, qualification, validation
- Experience in laboratory testing techniques, assay development, or analytical method validation for the manufacturing industry
This role is based in Brisbane and is a site-based position covering maternity leave.
Estimated Salary:$90,000 - $110,000 per annum, depending on experience.
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