IT Works Health LTD
Quality Control Lead
England
Posted 1 day ago
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Key Responsibilities
- Lead and support a team of QC analysts/scientists, managing workload, priorities, and day-to-day laboratory activities.
- Oversee QC testing across areas such as analytical, microbiology, biochemistry, or molecular testing, depending on the laboratory.
- Ensure all testing is performed in accordance with GxP, GMP, SOPs, and regulatory requirements.
- Review and approve analytical data, results, deviations, OOS/OOT investigations, and laboratory documentation.
- Support method validation, method transfer, equipment qualification, and laboratory investigations.
- Work closely with QA, R&D, Manufacturing, and other technical teams to resolve quality issues and maintain compliance.
- Identify opportunities to improve laboratory processes, systems, and efficiency.
- Support the implementation and use of laboratory systems, including LIMS, where required.
- Coach and develop team members, ensuring appropriate training and competency are maintained.
- Contribute to audits, inspections, and continuous improvement initiatives.
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Key Requirements
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- Previous experience leading a QC laboratory team within a pharmaceutical, biotech, medical device, or other regulated environment.
- Strong knowledge of GMP/GxP and QC laboratory processes.
- Experience with investigations, deviations, OOS/OOT, and CAPA.
- Understanding of analytical testing, laboratory systems, and data integrity.
- Strong leadership, communication, and stakeholder-management skills.
- Experience working with LIMS or other laboratory informatics systems would be advantageous.
- Relevant scientific degree or equivalent laboratory experience.
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Skills
QC Leadership
GMP
GxP
Analytical Testing
Microbiology
Biochemistry
Molecular Testing
OOS/OOT Investigations
CAPA
Method Validation
Equipment Qualification
LIMS
Data Integrity
Stakeholder Management
Laboratory Documentation
Compliance
Location