Senior Quality Associate
BiomeBank, Australia
Job Description
About BiomeBank
BiomeBank is a leading microbial therapeutics company providing the world’s first approved donor derived microbial therapeutic product. In addition, BiomeBank is pioneering the development of defined microbial therapies. With a TGA accredited GMP production facility and research and development laboratory established in Thebarton, South Australia.
The Senior QA Associate is responsible for supporting the Head of Quality in the overall implementation, management and maintenance of the GMP standard, and Quality Management System within BiomeBank. This will support manufacturing our donor derived microbiome-based therapy (biologic).
As part as BiomeBank's ongoing growth, a new manufacturing site is currently being established in Adelaide.
Requirements
The successful candidate will be supporting the Head of Quality and the QA team in the overall development, implementation, management and maintenance of the GMP standard, and Quality Management System at the new site and ensure a smooth transition from the current premises.
- Act as the Deputy in the absence of the Head of Quality.
- Establish or update company procedures, forms, working procedures related to existing process and new projects
- Participates in the documentation of changes by appropriately raising any changes control related to facility, documentation, equipment etc.
- Ensure timely closure of open change control.
- Lead or participate in Quality Risk Management activities.
- Report and investigate non-conformances and deviations, establish appropriate CAPA plan. Ensure timely closure of open deviations and CAPAs.
- Supports the review and approval of manufacturing batch records and related donor clearance document to ensure quality, safety, efficacy and integrity of FMT product manufactured at BiomeBank.
- QC checks and release of incoming materials and the final FMT product as required.
- Organise the mock recall periodic testing and supports recall activities.
- Support periodic disaster recovery testing.
- Support staff training on GMP and new processes.
- Lead or support qualification of equipment, processes and revalidation activities (including computerised system, process validation).
- Review and approve preventative maintenance, cleaning, calibration records, environment monitoring reports, alarm challenge report.
- Oversee the environment monitoring program and report non-conformances.
- Conduct supplier audits, qualification of new vendors and perform annual vendor reviews.
- Ensure valid contracts and QA Agreements are in place.
- Champion, support and pursue continuous improvements throughout the organisation.
Desirable skills, experience, and attributes for this role:
- Excellent understanding of GMP standard.
- Ability to analyse problems, identify alternative solutions and implement recommendations for resolution of problems.
- Attention to detail for building and maintaining quality; proficient at reviewing and editing documentation.
- Auditing skills and excellent documentation practices to accurately identify and communicate compliance issues discovered during the audit process.
- Effective written/oral communication (with excellent presentation and training skills), interpersonal skills, facilitation, and influencing skills for positive internal and external audit/meeting outcomes.
- Experience in Quality Management Systems and development of procedures with relevant GMP standards.
- A minimum of 5 years QA (or QC) experience in GMP environment is required for this role.
Benefits
- Great company culture
- Innovative new technologies
- Great opportunity in a fast moving start-up
- Diverse workforce