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Laboratory Manager
Date: May 12, 2025
Laboratory Manager - QC Chemistry
(25 13)
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 Laboratory Manager QC Chemistry to join Terumo BCT - Larne. Come join us today.
The successful candidate will oversee activities related to Quality Control within the Analytical Chemistry team to meet internal, regulatory, and customer requirements, engaging in continuous improvement initiatives.
1. General Duties
- Supervise and coordinate all analytical Quality Control work in accordance with approved methods and systems to ensure, through inspection and testing, that no materials or products are used or dispatched that fail specifications.
- Coordinate with production activities, implement additional testing where necessary to ensure high confidence levels in the process.
- Prepare and review Standard Operating Procedures, specifications, validation protocols, and product specifications.
- Review and approve raw materials, in-process materials, components, and finished goods analytical results.
- Assist in developing and validating new analytical methods and specifications.
- Ensure all materials required for laboratory use are ordered, and maintain sufficient reference samples for incoming goods inspection, testing, and analysis of in-process and finished goods without delay.
- Apply robust root cause analysis tools for investigating, reviewing, and reporting OOS results.
- Manage CAPA investigations and develop effective verification of effectiveness (VoE) plans.
- Monitor and report relevant metrics, including improvement and quality goals for the laboratory.
- Coordinate calibration and validation programs for laboratory instrumentation.
- Collaborate with R&D on test method re-validation programs.
- Develop, maintain, and review competency assessment plans for all Analytical Chemistry staff.
- Maintain and review GMP compliance across all areas.
- Liaise with other department heads as needed.
- Assist with investigating customer complaints as requested by the customer or QA department.
- Reallocate resources to accommodate urgent testing requirements.
- Assist in implementing and revising the site quality system.
- Participate in internal and external audits of the quality management system and respond to findings appropriately.
Educational Qualifications
- A degree in Chemistry or a closely related subject.
Experience
- Minimum 5 years of experience working in a Chemistry Laboratory.
- Minimum 2 years' experience within a Pharmaceutical or Medical Device environment.
- Experience managing staff.
- Knowledge of current EP/USP methods.
Skills
- Strong data interpretation and problem-solving skills.
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 portal, mySource, before the closing date of 5:00 pm on Monday, 26 May 2025.
You must clearly demonstrate on your CV/application how you meet the required criteria; failure to do so may result in not being shortlisted.
Join us in driving progress and supporting patients locally and globally every day by contributing to society through healthcare.
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