
Lab Quality Assurance Specialist
1 day ago
Our laboratory requires a seasoned Quality Assurance Specialist to oversee the establishment and maintenance of high-quality processes in our Sydney facility.
About the RoleThis critical position demands hands-on experience in quality control within the pharmaceutical, biotechnology, or related laboratory environment. The successful candidate will be instrumental in setting up our lab infrastructure, transferring analytical methods, and ensuring data integrity and efficiency.
Key Responsibilities- Establish and implement quality management systems for the new QC laboratory.
- Develop and execute plans for method transfer, validation, and qualification for internal use.
- Create robust documentation procedures for compliance and regulatory purposes.
- Conduct quality testing of incoming raw materials and perform in-process quality assessments.
- Execute final product testing to support batch release and investigate any out-of-specification results or quality deviations.
- Maintain high standards of Good Manufacturing Practice (GMP) documentation and record-keeping.
- 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 quality assurance.
- Excellent attention to detail, organization, and problem-solving skills.
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