Job Description

Reporting to the Quality Manager, the Associate Quality Assurance Specialist (Shift IPT) role is critically important to ensure Quality oversight and support for the IPT. You will be responsible for supporting multiple Quality Assurance strategies, systems and processes.

The candidate will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs, Health Agency regulations and all other applicable governing regulations. An expectation as part of the team will be to also drive a Quality culture for the site.

You will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Together, the team will build the future through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.

You will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

Our Quality Assurance group ensures all materials inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements as well as ensuring that all equipment is adequately qualified.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Quality Assurance Specialist within our company is required to

• Work a 4 shift pattern role
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Support the annual product quality reviews if required

Job Description

Reporting to the Quality Manager, the Associate Quality Assurance Specialist (Shift IPT) role is critically important to ensure Quality oversight and support for the IPT. You will be responsible for supporting multiple Quality Assurance strategies, systems and processes.

The candidate will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs, Health Agency regulations and all other applicable governing regulations. An expectation as part of the team will be to also drive a Quality culture for the site.

You will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Together, the team will build the future through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.

You will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

Our Quality Assurance group ensures all materials inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements as well as ensuring that all equipment is adequately qualified.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Quality Assurance Specialist within our company is required to

• Work a 4 shift pattern role
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Support the annual product quality reviews if required