Job Description

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Senior Quality Associate / Deputy QA

Advertiser: The Hospital Research FoundationMore jobs from this company

Job Information

Job Listing Date
23 Feb 2021
Location
Adelaide
Work Type
Full Time
Classification
Science & Technology, Quality Assurance & Control
  • BiomeBank - First public stool bank in Australia
  • Family Friendly and Flexible
  • Participate in faecal transplant clinical trial research

The Hospital Research Foundation (THRF) is a shareholder of BiomeBank and supported BiomeBank for five years before it became its own commercial entity in 2019.

BiomeBank is a clinical-stage biotechnology company developing microbial therapies for patients with unmet medical need. BiomeBank's mission is to treat and prevent disease by replenishing gut microbial ecology.

BiomeBank is Australia’s first public stool bank and microbial therapeutics company, established to treat debilitating bowel conditions and foster research into gut health. BiomeBank is pioneering gut microbiome research in Australia. With an established safe stool bank to facilitate faecal microbiota transplantation (FMT) and great microbiome science for next generation therapies, we are changing the way bowel conditions are treated in the community.

About the Role

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 in the frame of manufacturing Faecal Microbiota Transplantation (FMT) product.

Specifically, the Senior QA Associate will deputise for all the tasks outlined in the absence of Head of Quality role in their absence.

Desirable skills, experience and attributes for this role:

  • Establish or update company procedures, forms, working procedures.
  • QC checks and release of incoming materials and the final FMT product.
  • Ensure all changes (facility, documentation, equipment) are adequately documented as change controls
  • Ensure timely closure of open change control
  • Report and investigate non-conformance's and deviations, establish appropriate CAPA plan. Ensure timely closure of open deviations and CAPAs
  • Review and approve manufacturing batch records and related donor clearance document to ensure quality, safety, efficacy and integrity of FMT product manufactured at BiomeBank
  • Release for supply in the absence of Head of Quality
  • Organise the mock recall periodic testing and supports recall activities
  • Support periodic disaster recovery testing
  • Support staff training on GMP
  • Lead or support qualification of equipment and revalidation activities (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
  • Participate in the 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

How to apply....

Please include your resume and cover letter giving us a brief overview of your previous relevant experience and what interests you particularly about this role. Please also enter as much of your Recent Work and Education History on the application in the space provided.

If you possess the highest standards of professionalism, are driven by achievement and are passionate about connecting with people to deliver life-changing outcomes we would like to hear from you!

Thebarton 5031 SA

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