Laboratory Manager – QC Chemistry
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 in QC Chemistry at Terumo BCT - Larne. Join us today!
The successful candidate will oversee activities related to Quality Control within the Analytical Chemistry team, ensuring compliance with internal, regulatory, and customer requirements, while engaging in continuous improvement initiatives.
- General Duties
- Supervise and coordinate all analytical Quality Control work according to approved methods and systems to ensure materials or products meet specifications.
- Interface with production to implement additional testing where necessary to ensure process confidence.
- Prepare and review Standard Operating Procedures, specifications, validation protocols, and product specifications.
- Review and release raw materials, in-process materials, components, and finished goods analytical results.
- Assist in developing and validating new analytical methods and specifications.
- Ensure all laboratory materials are ordered and reference samples maintained for testing without delay.
- Apply root cause analysis tools for investigating OOS results.
- Own CAPA investigations and develop verification of effectiveness plans.
- Monitor and report on laboratory metrics, including improvement and quality goals.
- Coordinate calibration and validation of laboratory instruments.
- Collaborate on test method re-validation programs with R&D.
- Develop and review competency assessment plans for Analytical Chemistry staff.
- Maintain GMP compliance across all areas.
- Liaise with other departments as needed.
- Assist with customer complaint investigations.
- Reallocate resources for urgent testing requirements.
- Implement and revise the site quality system as required.
- Participate in internal and external audits, responding to findings appropriately.
- Educational Qualifications
- A degree in Chemistry or a closely related subject.
- Experience
- Minimum 5 years in a Chemistry Laboratory.
- At least 2 years’ experience in a Pharmaceutical or Medical Device environment.
- Management experience of staff.
- Knowledge of current EP/USP methods.
- Skills
- Effective written and oral communication skills.
- Strong data interpretation and problem-solving skills.
If you're ready to make a significant impact in a dynamic, collaborative environment, apply via our Terumo BCT career portal before 5:00 pm on Monday, 26 May 2025. Ensure your CV clearly demonstrates how you meet the required criteria, as failure to do so may affect your shortlist.
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