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Job Description
Business Job Title: Quality Assurance Specialist
Job Profile Title: Quality Specialist
Direct Report To: Quality Manager
Group/ Division: Life Sciences Solutions/GSD
Career Track: Professional
Position Location: Warrington
Number of Direct Reports: 0
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
The site in Warrington is growing fast and the QA Team is expanding to support this growth. The role in QA is diverse and challenging ensuring the customer is central to everything we do. Problem solving with external and internal customers is a key aspect of QA life along with driving process improvement across all aspects of the QMS.
Position Summary:
Works closely with customer facing teams, manufacturing and other back office functions to support customer bases ensuring alignment with site operational processes and procedures. Expected to take initiative and drive change across the business in order to promote product quality improvements, compliance and efficiency especially related to the interactions with the Pharma business.
Assists with QMS processes ensuring compliance with ISO13485/ISO18385/Global and Corporate Policies - seeking continuous improvement and promoting all aspects of the QMS.
Works with R&D groups and Warrington QA & NPI teams focusing on sustaining improvement projects & new product introductions to improve product quality/increase growth e.g., complaint reduction or yield/process improvements, new products or sustaining projects.
Responsibilities:
This position will support QA related daily management tasks such as batch review and product release/generation of CofAs/archiving of records/customer queries/general QMS support. The Quality Admin accuracy is critical to customer facing documents so attention to detail is very important.
This position closely interacts and builds effective relationships with people across site to promote
quality, consistency and compliance thus providing quality support to manufacturing and NPI projects. This position demonstrates courage and willingness to determine appropriate action and make risk-based timely decisions to support the customer, operations and compliance.
This position Identifies and drives improvement opportunities through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.
This position takes responsibility for the measuring and monitoring of performance against agreed KPI's including collating and sharing of information/data and trending as appropriate through reports and thus follows up on improvement opportunities.
This position will be able to take part in/facilitate risk assessments (PFMEA/FMEA) to assist in improving both product and processes. This position will be a QA lead on CAPA projects (ensuring product/process improvements are executed in a timely manner).
This position will ensure that auditing is used as a proactive tool for improvement as well as compliance and allows challenges to existing practices where appropriate.
This position contributes to timely completion of audits and follow up through to closure ensuring corrective actions are completed in a timely manner.
This position will support the change control process ensuring compliance with ISO/Corporate guidelines and championing process improvements. This position will take an active role in the customer notification process ensuring change notification is effectively managed and customer needs are considered at all times.
Minimum Requirements/Qualifications:
• Degree in a scientific discipline or equivalent experience in a relevant discipline.
• Knowledge of ISO9001/13485/ or equivalent standards (ISO18385 and auditing to a quality standard an advantage).
• Experience of ISO14971/FMEA/PFMEA an advantage.
• Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts).
• Experience of CAPA processes & problem solving within Process/Product Improvement multi-functional teams – knowledge of trackwise an advantage
• Ability to work on multiple tasks at any one time.
• Excellent communication and report writing skills.
• Ability to recognise deviation from requirements and understanding risks when decision making.
• Experience of office packages and general computer skills – knowledge of SAP/Agile an advantage
• Ability to challenge existing approaches to compliance in order to seek improved ways of working.
• Ability to coach and influence others is essential.
• Travel requirements – some travel maybe required – 10% max
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
