QC Bioassay Analyst

Speke
1 day ago
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QC Bioassay / Incoming & Components Analyst

📍 Location: Merseyside

📅 Contract: 6 Months

🏢 Company: Global Biopharmaceutical Organisation

Overview

We are supporting a global biopharmaceutical organisation based in Liverpool in the search for an experienced QC Analyst to join their Quality Control team on a 6-month contract.

This role will focus on the compliant execution of QC testing, inspection, and release activities across both bioassay and incoming materials/components, supporting critical vaccine manufacturing operations.

You will also contribute to technical and validation studies, ensuring alignment with both departmental and site objectives.

Key Responsibilities

QC Bioassay

* Perform QC testing on in-process, intermediate, and finished vaccine products

* Conduct data review and interpretation in line with approved SOPs

* Ensure all work is carried out in compliance with cGMP and regulatory standards

* Accurately document all laboratory activities, ensuring data integrity

* Support method validation, transfer, and technical studies

QC Incoming & Components

* Perform primary QC inspection and sampling of raw materials

* Conduct testing of primary and secondary packaging components

* Review and interpret analytical data in accordance with SOPs

* Support the release of raw materials and components for manufacturing

* Assist in deviations, investigations, and CAPA activities

Requirements

* Fluent in English (written and verbal)

* Proven experience in QC testing techniques relevant to the role (bioassay and/or raw materials/components testing)

* Strong experience working within a cGMP-regulated environment

* Clear understanding of GMP compliance, documentation, and data integrity principles

* Awareness of equipment qualification and method validation requirements

* Understanding of root cause analysis and its application within investigations

* Strong IT skills with experience using electronic laboratory and quality systems (e.g. LIMS, electronic documentation systems)

* Demonstrable experience working within the pharmaceutical or biopharmaceutical industry under cGMP conditions

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