Senior Quality Assurance Specialist
4 weeks ago
KE Select is a leading recruitment firm specializing in Scientific and Medical placements. With extensive networks across ANZ, we've become the go-to recruiter for organizations in Life Science, Medical Device, Clinical Diagnostics, and Pathology.
We are partnering with a prominent Global organization to hire a Quality Scientist for their Brisbane-based site. This company excels in commercial and clinical manufacturing, catering to Pharmaceutical, Biotechnology, and Life Science sectors.
The successful candidate will report directly to the quality leader, ensuring technical transfer and validation processes meet quality and regulatory standards. This role involves interacting with customers and providing support for QC equipment compliance.
About the Role:- Client management on specific projects, handling expectations and challenges
- Preparing batch documentation/data, reviewing protocols, and generating reports
- Investigating new methods/techniques and managing control activities
- Liaising with internal stakeholders, particularly QC laboratory teams, for issuing relevant test methods
- Authoring analytical method transfer, feasibility, qualification, and validation protocols/reports according to internal policies and regulatory guidelines
- Implementing Quality System principles, Change Control, Deviations, CAPAs, and Document Management within the Quality Control Department
Key Requirements:
- Bachelor of Science (Chemistry, Biochemistry, Biotechnology)
- Knowledgeable in GMP, NATA, and cGMP
- Ability to work in a dynamic environment with diverse perspectives and people
- Proven ability to work as a team member and independently when required
- Effective communication skills in multiple formats (electronic, written, verbal)
- Experience with test method development, qualification, and validation
- Background in laboratory testing techniques, assay development, or analytical method validation for the manufacturing industry
Compensation Package:
We estimate a competitive salary range between $80,000 - $110,000 per annum, commensurate with experience and qualifications. The exact compensation package will be discussed during the interview process.
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