Quality Control Technical

BioLegend, Inc.; Llantrisant; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading Biotechnology Company in Llantrisant seeks a Quality Control Technician to ensure product integrity and compliance with ISO9001:2015 and ISO13485:2016 standards. Responsibilities include managing quality inspections, overseeing reject and quarantine areas, and driving quality improvement initiatives. Ideal candidates should possess strong technical knowledge, attention to detail, and familiarity with relevant ISO standards. Join our team to contribute to delivering high-quality products precisely and reliably.

Qualifications

• Experience in Quality Control, preferably in a regulated environment.
• Knowledge of ISO9001:2015 and ISO13485:2016 standards.
• Ability to read and interpret technical drawings.

Responsibilities

• Ensure product integrity and compliance with quality standards.
• Conduct inspections of materials and manage reject and quarantine areas.
• Environmental monitoring within controlled environments including air particulate monitoring.

Skills

Technical knowledge in Quality Control

Problem-solving abilities

Attention to detail

Knowledge of ISO standards

Tools

SAP

Oracle Fusion

Job description

Purpose

The Quality Control Technician ensures product integrity and compliance with ISO9001:2015 and ISO13485:2016 standards, reporting to the Quality Manager. Responsibilities include inspection of materials, management of reject and quarantine areas, and environmental monitoring, all supported by SAP and PDM systems.

This role directly contributes to delivering reliable, high-quality products to customers and end users, safeguarding performance and safety.

Key Responsibilities

• Working under both ISO9001:2015 and IS013485:2016 certificates and collaborating with Product Quality Engineer and Supplier Quality Engineer to achieve the intended outcomes for both

• Independent ownership of Quality Control function, utilising technical knowledge and experience for problem solving in order to prevent Quality escapes and to reduce cost of poor quality against targets

• Technical support for PQE and SQE when required.

• Reading / interpreting of technical drawings to establish specifications as part of root cause analysis and evaluation of sampling parts

• Ownership of reject processing i.e. RTV sheet and returns - with SAP and Oracle Fusion access

• Ownership of Quarantine location – follow up on dispositions – drive weekly review on actions to drive down Quarantine inventory through disposition channels

• Routine stock-check of SS blocked (Quarantine) location – SAP report and compare

• Attendance of Inventory (blocked stock) meetings and providing updates and information as required

• Identifying opportunities for cost saving via rework instead of scrap activities

• Initiating scrap requests via the portal on behalf of PQE

• Stock inspection when issues arise to AQL for batch quantities and / or 100% inspection when required

• Carrying out reject trend analysis and highlighting to PQE and SQE any emerging reject trend or in-house scrapping issues.

• Incoming inspection for FAI process, Problem parts on incoming block (supporting SCAR process), Certain critical components as perpetual inspection items (e.g. those under ISO13485:2016)

• Random inspection of outgoing instrument documentation (ISO9001:2015)

• Inspection of outgoing instrument documentation (ISO13485:201)

• In-process Quality Inspections for high risk processes as identified

• Environmental monitoring and documentation within the controlled environment including: Air particulate monitoring andTemperature and Relative Humidity monitoring

• Maintenance of COPQ savings log in order to report to Senior Leadership on a quarterly and annual basis.

• Taking part in and driving Quality Spot-Check investigations in collaboration with PQE/ SQE to root cause and creating a report to be escalated to formal non-conformance via the CAPA system

• Membership of internal audit team