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QC Specialist
CAI
Melbourne, AUS
Full-time
Onsite
Discovered 2 weeks ago
Quality controlPharmaceutical laboratory operationsLaboratory instrumentationAnalytical testing techniquesAnalytical method transferMethod validation
Free
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Quality controlPharmaceutical laboratory operationsLaboratory instrumentation
Key Skills for This Role
Quality controlPharmaceutical laboratory operationsLaboratory instrumentationAnalytical testing techniquesAnalytical method transferMethod validation
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About CAI
CAI is a professional services company serving Life Sciences and Mission Critical industries.
The company provides operational readiness, field-tested processes, and technical expertise for high-stakes environments.
Position Responsibilities
- Assist with setup and operationalization of the new quality control laboratory.
- Lead or support analytical method transfer, validation, and qualification for internal use.
- Implement procedures for method documentation and compliance.
- Test incoming raw materials against quality specifications.
- Conduct in-process quality assessments for manufacturing and scale-up activities.
- Execute and document final product testing to support batch release.
- Investigate out-of-specification results and quality deviations with QA.
- Maintain GMP documentation and records.
- Support development of SOPs, forms, and test records.
- Assist with audits, internal inspections, and continuous improvement.
Candidate Requirements
- Prior hands-on quality control experience in a pharmaceutical, biotechnology, or related laboratory environment.
- Strong knowledge of laboratory instrumentation and analytical techniques for raw material and finished product testing.
- Experience with method transfers and laboratory setup is highly desirable.
- Understanding of GMP, GLP, and regulatory expectations related to quality control.
- Excellent attention to detail, organization, and problem-solving skills.
- Ability to work autonomously in a fast-moving, start-up-style environment.
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