Quality Specialist
Date: Jan 20, 2025
Location: Larne Harbour, ANT, GB
Company: Terumo BCT, Inc.
Terumo BCT is a global leader in blood management, blood safety, therapeutic apheresis, cell therapy, and cell collections. We have an exciting opportunity for a Quality Specialist to join Terumo BCT - Larne Sites. The successful candidate will provide quality support for the business by assisting management in complying with worldwide regulatory requirements. Investigate customer complaints, review records, and provide other services to this end. Act as a contact point regarding customer complaints.
Essential Duties
* Receipt, decontamination, and investigation of returned BCT disposables.
* Works independently to accomplish established objectives, performs varied quality/regulatory activities such as: investigation and coordination of customer product quality complaints, processing of returned goods, and performance of regular quality system audits.
* Progression to Adverse Event Reportable Complaints which may result in Field Action Evaluation decisioning.
* Participates in continuous improvement projects, both process and product-related.
* Works in conjunction with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to intermediate complexity. Interprets, executes, and recommends modifications to operating policies where appropriate.
* Provides accurate and timely turnaround on complaints, returned goods, and other activities. Maintains related reports that are accurate and concise.
* Independently designs and performs routine testing, project experiments, analysis of data, and reports results.
* Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions.
* Customer-centric approach, ability to implement a flexible work schedule.
* Responsible for fulfilling FDA and international regulatory requirements relevant to each project, such as GMP, IDE, PMA, 510(k), and ISO.
Education
* Degree in Life Science, Engineering, or relevant subject.
Experience
* Minimum two years’ experience in a quality-related role within a pharmaceutical/medical device manufacturing environment.
Skills
* Good PC skills (i.e., MS Office, databases, etc.).
* Excellent interpersonal and communication skills.
* Tactful and diplomatic whilst remaining assertive and persistent.
Attributes
* Knowledge of manufacturing protocols, statistical tools and methodologies, and continuous improvement techniques.
* Able to work as part of a team.
* Ability to work to strict deadlines.
* Takes ownership of issues/problems and actively seeks to resolve them.
If you're ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV via our Terumo BCT career’s portal mySource before the closing date of 5:00 pm on Monday, 03 February 2025.
You must clearly demonstrate on your CV/application how you meet the required criteria as failure to do so may result in you not being shortlisted.
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