CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
Position Description
- Assist with the setup and operationalization of the new QC laboratory.
- Lead or support the transfer, validation, and qualification of analytical methods for internal use.
- Implement robust procedures for method documentation and compliance.
- Perform quality testing of incoming raw materials to ensure conformance with specifications.
- Conduct in-process quality assessments to support manufacturing and scale-up activities.
- Execute and document final product testing to support batch release.
- Investigate any out-of-specification results or quality deviations in coordination with QA.
- Maintain high standards of GMP documentation and record-keeping.
- Support the development of Standard Operating Procedures (SOPs), forms, and test records.
- Assist with audits, internal inspections, and continuous improvement initiatives.
Requirements
- Prior hands‐on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
- Strong knowledge of laboratory instrumentation and analytical techniques relevant to 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 QC.
- Excellent attention to detail, organization, and problem‐solving skills.
- Ability to work autonomously and adapt to a fast‐moving, start‐up style environment.
QC Specialist in Sydney employer: CAI
CAI is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the advanced therapeutics sector. Located in Sydney, employees benefit from a vibrant city life while engaging in meaningful projects that drive personal and professional growth. With a strong emphasis on training and development, CAI empowers its team members to excel in their roles and contribute to impactful outcomes in GxP compliance.
