At Vaxxas, every detail matters: We are currently SEEKing a precision-driven Senior Quality Control Analyst, specialising in Microbiology.
About Vaxxas
Vaxxas is a privately held, clinical stage biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology.
The company's innovative, needle-free technology can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation, easing the resource and logistics burden of maintaining the vaccine cold chain.
In addition to a Phase I clinical study of a COVID-19 vaccine candidate, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions, among multiple other clinical and preclinical programs.
The company has forged collaborations with leading global organisations in vaccine commercialisation, including Merck/MSD, CEPI, the World Health Organization (WHO), and the Gates Foundation.
Learn more at
Overview of position
The Senior Quality Control Analyst role, specialising in microbiology, will be part of a team involved with validation and method transfer, final product testing, environmental monitoring, highly purified water testing, and other QC processes, including incoming goods. This role will be responsible for working within the QC team to develop, draft and review Quality Control documents, such as procedures and protocols. They will be the Microbiologist involved in investigations, site document inputs and review, and have an active role involved in multifunctional teams, as required. The Senior Quality Control Analyst takes on a mentoring role to less experienced colleagues, setting examples, sharing information and providing process related feedback.
Duties & Responsibilities
* Compose, review, and perform investigations, such as OOS, deviations and CAPAs.
* Design validation and perform or outsource Microbiological Analysis,
* Organise, author and perform validation of QC equipment.
* Ensure compliance with SOPs and applicable regulations.
* Assist in the development and improvement of the Environmental Monitoring Program and other QC processes.
* Perform Environmental Monitoring and highly purified water sampling, testing, and trending.
* Author documentation for and perform test method transfer.
* Compose and review technical documentation (protocols, procedures, methods, and reports).
* Design and conduct stability studies according to ICH guidelines.
* Perform QC inspections, labelling and disposition of incoming materials and verifying correct storage.
* Training delivery in areas of expertise, as required, ensuring relevant personnel are trained on the procedures and requirements.
* Implement and improve upon QC systems, in line with best practice Operation Excellence.
* Maintaining safety and GMP quality standards including in GMP manufacturing in GMP manufacturing classified areas.
Qualifications
* Bachelor's degree in a scientific field, Microbiology preferred.
* 5+ years Quality Control Microbiology experience within the GMP pharmaceutical/biotech/medical device sector.
* GMP manufacturing in classified areas - The employee is required to successfully complete a pre-employment medical, along with periodic medical examination once employed / engaged.
Desired knowledge, skills and abilities
* Aseptic technique and demonstrated experience in testing or working with low bioburden/sterile product.
* Experience in participating in microbiological testing both for starting material and finished product.
* Utilising strong problem-solving skills to perform in depth investigations and root cause analysis.
* Insightful and experienced in the following: validation of test methods, method transfers, validation of analytical equipment, environmental monitoring processes.
* Experience in Assay and Method validation and microbiology analysis.
* Experienced in providing microbiological guidance and input into site processes.
* Advanced computer skills with proficiency in Microsoft applications (Word, Excel), and an ability to learn other computer-based systems.
* Knowledge of working to GMP standards and regulations appropriate to QC.
* Successful completion of a pre-employment medical examination.
If you're a self-starter with a passion for Quality Control and thrive working in a fast-paced, rapidly changing environment, we encourage you to apply for this exciting opportunity.
To be considered, please submit your Resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the 'apply for this job' function. You will be contacted directly if your application is successful.