Senior QA Associate
PolyNovo Limited
full-time
Posted on:
Location Type: Hybrid
Location: Port Melbourne • Australia
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Job Level
About the role
- Provide Quality Assurance support across manufacturing, supply chain, regulatory affairs, product development, and sales and marketing functions
- Ensure documentation complies with the company’s QMS requirements and relevant regulatory requirements
- Assist with Internal Audits to ensure compliance to local and global regulatory requirements
- Assist with external audits by regulatory authorities/notified bodies
- Assist staff in defining key product/service requirements for potential new suppliers as part of the supplier approval process
- Participate as the QA delegate in new product development, validation activities and project activities
- Perform batch disposition and release for supply activities by ensuring all outstanding actions are completed according to set procedures and regulatory requirements
- Work cross functionally with key stakeholders to assess and resolve quality issues
- Review the coordination of the handling of non-conformances across all areas of the company
- Monitor manufacturing data for compliance and improvement opportunities
- Analyze quality assurance gaps and make necessary changes in consultation with process stakeholders
- Assist department managers with staff training needs related to the quality management system
- Coordinate with departments the actions and timeframes required to close product temperature excursions and customer complaints
- Act as 2IC to QA Manager, and work at a higher level in their absence
- Other QA related tasks as required
Requirements
- Degree qualification (minimum) in a science, biomedical/biotechnology or related discipline
- Preferably 3 years’ plus experience in a quality related role within a medical device/pharmaceutical manufacturing or engineering organisation regulated by ISO13485 and/or GMP/FDA 21 CFR820
- Good understanding of ISO 14971 risk management processes and the application in a manufacturing environment
- Operate with a high degree of independence and to exercise independent judgement in the performance of duties
- Proven ability to take accountability for the quality and timeliness of their work outputs
- Works collaboratively with all levels within the organization in relation to maintaining Quality System assurance and compliance
- Support the production of all products through provision of Quality compliance advice
Benefits
- Unique platform technology, an exciting pipeline of highly innovative products
- Diverse, inclusive and flexible workplace culture
- Career development opportunities and unlimited access to online learning
- Rewards platform with access to discounts at over 450+ Australian retailers
- Paid parental leave for primary and secondary carers
- Nurture Days
- Salary packaging including novated car leasing
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality AssuranceISO 13485GMPFDA 21 CFR 820ISO 14971risk managementbatch dispositionregulatory compliancedocumentation complianceinternal audits
Soft Skills
independent judgementaccountabilitycollaborationcommunicationproblem-solvingtrainingstakeholder engagementanalytical thinkingattention to detailleadership