Full-Time Technical Lab Operations Specialist

• Run the lab end-to-end: Ensure a safe, organized, and inspection‑ready laboratory supporting diagnostics R&D and prototyping.
• Equipment management: Own calibration, preventive maintenance, and service schedules; keep compliant equipment logs and vendor/service records.
• Sample & inventory flow: Oversee sample accessioning, cold‑chain storage (incl. freezers), and consumables/reagent inventory to support assay workflows.
• SOPs & documentation: Draft, update, and control SOPs, work instructions, and training records to maintain consistency and compliance.
• Quality & compliance: Align daily ops with UK/EU frameworks (ISO 13485, ISO 15189, IVDR, UKCA); support audits, CAPA, and change control.
• Workflow enablement: Partner with scientists, engineers, and bioinformaticians to streamline processes, support assay roll‑outs, and optimize throughput.
• Data & LIMS: Champion LIMS/ELN use and data integrity; ensure accurate capture of metadata, results, and QC records.
• Cross‑functional liaison: Act as the operational bridge across R&D, engineering/automation, QA/RA, and clinical teams.
• Admin backbone: Handle purchasing, scheduling, vendor coordination, and lab housekeeping to keep the engine running.

• Degree (or equivalent practical experience) in life sciences, biomedical/biochemical engineering, or related field.
• 5+ years in lab operations within diagnostics/medical devices/biotech.
• Strong understanding of ISO 13485 and regulated lab environments; exposure to ISO 15189, IVDR, or UKCA is a plus.
• Hands‑on experience with SOPs, controlled documents, audits, CAPA, and change control.
• Practical knowledge of equipment calibration/PM and troubleshooting.
• Bonus: Familiarity with LIMS/ELN and data integrity principles.
• Excellent organizational skills; adept at prioritizing multiple workflows.
• Clear communicator and collaborator across technical and non‑technical teams.
• Experience in high‑growth/startup environments is a strong plus.

• Proactive owner with a strong bias to action and continuous improvement.
• Low‑ego, high‑collaboration mindset that elevates teammates.
• Mission‑driven, patient‑centered approach.

• Exposure to lab automation (liquid handlers, scheduling software).
• Awareness of AI/data integration with laboratory workflows.
• Experience working with blood samples, or related biological materials.
• Prior industry exposure, particularly in regulated or translational settings, is desirable.

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