Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
We are currently recruiting for the role of Quality Assurance Associate to join our team in Perth on a permanent basis.
The core of the role will be the review and approval of all BMRs (Batch Manufacturing Records), this will include the input of data into SAP for batch release purposes. Document/data control and maintenance of the QMS (Quality Management System) will also be key in the role.
- Review production documentation for completeness and accuracy to allow for timely release of product
- To liaise with Operations personnel for process parameter definition and recording.
- Precisely Identify where documentation does not comply with latest Thermo Fisher Perth documentation requirements
- Responsible for reviewing and approving quality documents and SOPs in line with local quality procedures.
- Maintaining QMS such as Change Control and NC/CAPA
- Perform internal audit to ensure compliance to external regulatory requirements.
- Assist in third party / customer audits as required
- Assist in metric data for the Quality department.
- Any other duties/projects as are reasonable and within the skills and ability of the post-holder.
- Excellent oral and written communication skills
- Must be a self-starter who can take general concepts and direction and produce desirable results.
- Strong working knowledge of various computer software, such as Microsoft Word, Excel and PowerPoint.
- Demonstrate attention to detail
- Experience within manufacturing environment with demonstrated ability to understand process or technical documentation
- Ability to work both independently and as a team member.
- Experience of working within a Medical device, GMP, ISO 9001 or ISO 13485 background
- Internal auditor trained / experienced
- Scientific background either via experience or qualification
- Experience of reviewing/ updating production documentation, SOPs or similar.
- Demonstrated working knowledge of compliance, quality and manufacturing documentation requirements
- Usage of SAP or related system
*LI - KP1