Job Title: Quality Assurance Specialist
We are seeking an experienced and skilled professional to join our team in Brisbane, Australia.
About the Role:
The successful candidate will be responsible for ensuring the quality of bio-pharmaceutical products, adhering to all Good Manufacturing Practices (GMP) safety standards.
Key Responsibilities:
* Liaise with clients and project managers regarding their quality requirements for stability studies, batch testing, external shipments, and external contract testing.
* Collaborate with quality control laboratories, quality assurance teams, program management, warehouse and logistics, third-party contract laboratories, equipment/maintenance vendors, and contractors.
* Generate shipping documentation and sample submission forms required for testing of client samples at external facilities.
* Review and approve test reports supplied from external facilities.
* Perform aseptic aliquoting of bulk samples.
* Support quality control laboratory teams as required to ensure relevant testing is performed on time and accordance with regulatory guidelines.
Requirements:
* Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
* At least 2 years' industry work experience in the pharmaceutical or biotechnology industry aligned to analytical and quality control fields.
* Knowledgeable with test method development, qualification, validation.
* Must be knowledgeable in cGMP practices and quality management systems (QMS) including experience with deviations, CAPA, OOS, OOT, document management, change control, etc.
The successful candidate will possess excellent communication skills, attention to detail, and the ability to prioritize multiple client programs and reports simultaneously.