The Quality Assurance Specialist (Shift IPT) role, reporting to the Quality Manager, is of paramount importance in coordinating shift priorities, providing guidance to QA IPT team members, and maintaining Quality oversight and support for the IPT. As a key member of the team, you will be responsible for implementing and supporting various Quality Assurance strategies, systems, and processes.
Your primary responsibility will be to uphold cGMP standards for the assigned areas, ensuring compliance with policies, Health Agency regulations, and other relevant governing regulations. Furthermore, you will play a vital role in fostering a strong Quality culture throughout the site.
Collaborating with a talented cross-functional team comprised of individuals from our company and the biotechnology industry, you will contribute to shaping the future by cultivating a Quality culture that enables us to deliver high-quality products to our patients with unmatched efficiency.
We are committed to your growth and development. You will receive active support and encouragement to enhance your knowledge and skills, with opportunities to expand your expertise in areas that align with your career aspirations and contribute to continuous improvement in your current role. Additionally, you will provide quality support to the site, including training and guidance on interpreting and implementing company Guidelines/Policies and regulatory requirements as needed.
Within our Quality Assurance group, we have stringent standards to ensure that all materials in our products are manufactured, processed, tested, packaged, stored, and distributed in strict accordance with our exceptional quality standards and meet all regulatory requirements.
What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
Work a 4-shift pattern role involving technical knowledge of sterile manufacturing processes.
Perform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns commensurate with the risk.
Respond quickly to unplanned events and technical issues (providing guidance to QA IPT team members for escalated issues)
Acts as Quality point of contact for the Quality Manager as required
Mentor of QAIPT shift Team members (providing guidance and technical support as required)
Lead continuous improvement initiatives to continually drive efficiencies and remove waste to help site deliver compliant products,
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Operate quality systems in a dynamic manufacturing environment (e.g., SAP, Trackwise, MES).
Have a full understanding of relevant quality and compliance regulations, including cGMP, US, and EU requirements.
Conduct, report, and display Quality right first time and audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
Support the spot check/walk-through process of the production lines.
Be involved in customer complaint investigation if required.
Support the annual product quality reviews if required.
Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
Preferably have an understanding of sterile manufacturing operations.
Have the ability to learn and utilize computerized systems for daily tasks.
Prioritize, manage multiple tasks, and meet deadlines.
Perform timely reviews on batch documentation (EBRs), line clearances, and assist in the resolution of concerns commensurate with the risk.
Liaise with other Department representatives to promote improvements in GMP and Quality standards.
Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.
Comply with current Manufacturing Division, Quality, and EHS Management System requirements, as relevant to commercial operations.
Foster a culture of continuous improvement by deploying Our Company MPS tools and support implementation of Model Area within operations from the start.
