Quality Assurance & Control (Science & Technology)
Full time
* SEEKing a Senior Quality Associate who thrives in complex environments and turns challenges into opportunities *
Overview
Reporting to the Quality Manager – Development and Validation, this role will be part of a team providing Quality support for the qualification of equipment, facilities and test methods used in the manufacture of preclinical and clinical products in compliance with (phase appropriate) GMP requirements.
The role will review risk assessments, user requirements, protocols and reports for validation activities associated within methods, facilities, utilities and equipment.
Duties & Responsibilities
Maintaining, and continuous improvement of the Quality Management System (QMS) and assisting the Quality team ensure appropriate SOPs are in place and highlighting compliance gaps.
Ensuring compliance with SOPs and applicable regulations.
Working with the Development and Validation team and other departments to develop and implement improved, compliant processes and systems.
Reviewing and approving qualification documentation.
Performing periodic review of validated state – equipment, facilities, processes and methods.
Completing or reviewing change controls, investigations, CAPAs, OOSs, supplier CARs, deviations and validation discrepancies.
Training delivery in areas of expertise as required, ensuring relevant personnel are trained on the procedures and requirements.
Performing and/or supporting internal and external audits and assisting with audits by external parties.
Qualifications
Science degree in a relevant discipline - completion of chemistry/biochemistry/microbiology/pharmacy science degree/s (preferred).
5+ years' experience in a similar role.
Validation experience within the pharmaceutical/biotech/medical device sector, ideally with Medical Device/Combinational product experience.
Desired experience and skills
Knowledge of: GLP, GMP, ISO standards for device development, regulations and compliance in one or more of the following regulatory frameworks: TGA, FDA, MHRA, EMA.
Knowledge and experience in any of the following: validation of process, equipment, facility, computer systems, cleaning, utilities, or analytical test methods, bioanalytical assay method development and validation, validation and verification, aseptic or biologics manufacturing.
Demonstrated problem-solving and critical thinking skills, task-orientated with a solutions-focused approach.
A high level of drive, enthusiasm and a 'can do' approach, comfortable working in a fast-paced, rapidly changing environment; a willingness to learn and to seek answers to problems and issues and propose solutions.
Advanced computer skills with proficiency with Microsoft applications (Word, Excel, Visio) and Adobe Professional, and an ability to learn other computer-based systems.
Excellent capabilities in self-managing, planning, organising, prioritising, and multi-tasking, independently and as part of a cross-functional team.
Manage priorities within prescribed timeframes.
Proven interpersonal and excellent communication skills (verbal/written/presentation) with the ability to work collaboratively with internal stakeholders and external partners.
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
If you are looking for a role to unlock your potential as a Senior Quality Associate, we want to hear from you!
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.
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