QC Team Lead
Overview
CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions-driven team members with a flexible approach who want to be part of the company’s continued success.
Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis, along with highly trained microbiological and analytical analysts on contract to clients across the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.
We offer bespoke managed service solutions, giving clients the flexibility of having our expert teams embedded on-site at their facilities or outsourcing those services to us here at CLS.
The Role
Reporting to the Associate Director of QC Operations, this position plays a key role within the Quality Control function. The successful candidate will be responsible for supporting QC instruments and equipment, sample management, and core compliance activities.
This role ensures adherence to the highest standards of Good Laboratory Practice (GLP), cGMP, regulatory requirements, and internal quality standards. As part of a dynamic and evolving project environment, responsibilities may expand in line with business and project timelines.
Key Responsibilities
Contribute as a key member of the QC team, supporting strategic objectives and business planning through effective cross-functional collaboration.
Develop and maintain strong competency in laboratory methods supporting raw material, utility, in-process, release, and stability testing of biotechnology products.
Perform routine and non-routine laboratory testing in line with approved methods and schedules.
Ensure all testing activities are completed, reviewed, and approved within agreed turnaround times.
Maintain full compliance with product licence commitments, cGMP, and company quality standards.
Lead and support project interactions with internal and external stakeholders including Quality Assurance, Regulatory Affairs, and Analytical Development.
Train QC analysts and manufacturing personnel in laboratory methods and procedures where required.
Author, review, and update Test Methods (TMs), Standard Operating Procedures (SOPs), and Work Instructions (WIs).
Investigate and document invalid tests, deviations, and non-conformances.
Initiate and drive change controls to completion, supporting continuous improvement initiatives.
Actively participate in Lean initiatives such as Kaizen, 5S, and Gemba.
Support additional responsibilities as required to meet operational and project needs.
Who You Are
A strong leader with demonstrated people management or supervisory experience.
A clear communicator with excellent interpersonal, verbal, and written communication skills.
A critical thinker with strong troubleshooting and problem-solving capabilities.
Highly organised, detail-oriented, and self-motivated.
Adaptable and comfortable in a fast-paced, evolving environment with shifting priorities.
Results-driven, capable of managing multiple priorities effectively.
Collaborative and inclusive in your approach to teamwork.
Where You Come From
A university degree in a relevant science or quality discipline.
Proven experience working within a Quality Control environment, ideally within the biologics or biopharmaceutical industry.
Experience in GMP material release and participation in QC activities such as method transfer and validation.
Working knowledge of FDA/EMA regulatory requirements, ICH guidelines, and GMP standards applicable to biologics and/or pharmaceuticals.
Experience operating within an FDA or HPRA-approved QC laboratory.
Experience with laboratory systems such as LIMS, Empower, ECM, MasterControl, TrackWise, or similar platforms.
Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, Visio, and Project.
Experience in a CMO environment and/or greenfield site start-up is advantageous.
Previous experience managing small teams or supervising personnel is desirable.
What We Offer
The opportunity to join Ireland’s leading contract laboratory during a period of significant growth.
A collaborative and supportive working environment.
Exposure to cutting-edge biopharmaceutical projects.
Ongoing professional development and career progression opportunities.
The chance to contribute meaningfully to quality excellence and continuous improvement initiatives.
If you are driven, adaptable, and eager to play a key role in a high-performing QC environment, CLS offers the platform to grow your career while making a real impact.
- Locations
- Dundalk
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