This role is to provide scientific and operational leadership across assay development, validation, and study delivery to achieve ISO 17025 compliance for designated methods. The role will be a project and technical manager and will ensure valid, reliable results, robust data integrity; and an effective management system aligned with ISO 17025 and applicable GxP regulations (e.g., GLP, GCP) to support accreditation and client confidence.
Responsibilities
* Serve as Technical Manager for assigned methods with overall responsibility for technical operations, competence, and method performance monitoring; define competence requirements, authorisations, and ongoing training.
* Maintain the laboratory's management system in alignment with ISO/IEC 17025 Clause 8 (documentation, document control, records, risk & opportunities, improvement, corrective action, internal audits, and management review).
* Oversee participation in proficiency testing/interlaboratory comparisons (as applicable), trending of quality control data, and timely investigation of out‑of‑trend/nonconforming results.
* Define, apply, and document decision rules when issuing pass/fail statements against specifications.
Project Management
* Demonstrates organisational skills – ability to work to agreed timelines; prioritise own work and that of individuals working on the project, providing direction where required.
* Assess resource requirements, communicate requirements to management/resourcing, develop awareness of project cost vs gain.
* Initiate problem‑solving of adverse events during method development, validation, study and non‑study work, encourage others to assist in providing solutions. Works with the Project Lead/Study Director to ensure that any issues/obstacles are documented correctly.
* Identify process improvements and new/further method developments and share with appropriate individual(s).
* Provide regular updates on project delivery, highlight any potential issues which may affect timelines, quality and/or cost to Project Lead.
Associated Documentation
* Review/write laboratory SOPs and lab sheets in line with process improvements for study‑related work.
* Prepare new SOPs and lab sheets in relation to new assay types/product lines.
* Prepare/assist with the development of training guides/records in relation to new assay types/product lines.
* Prepare reports prior to QA audit and dispatch to the client as audited draft within chosen scientific discipline (10%).
* Produce a summary report of any method development/validation process undertaken and completed.
* Address eQA comments regarding procedures, raw data, and reports.
* Assist Project Lead to prepare protocol and report templates for new product lines.
* Assist in the preparation of validation protocols for new study types and/or method developments.
Qualifications
* Degree in Biomedical/Forensics/Biological Sciences or equivalent is preferred but not essential.
* Recognised project management and in‑vitro toxicology experience.
* Technical competence of routine and specialised aerosol generation techniques across a wide range of industrial applications.
* Experience of cross‑site collaboration helping to drive harmonisation.
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