As QC Operations Scientist, you will be responsible for tasks supporting computer systems, sample management, and general QC-compliance functions, ensuring adherence to Good Laboratory Practices, regulatory requirements, and quality standards. The role will evolve based on project timelines.
Organisation Description
WuXi Biologics is a leading provider of biologics services from discovery to commercialization, serving global biopharmaceutical and healthcare clients. We are among the top three contract development and manufacturing organizations for biopharmaceuticals, with a mission to accelerate biologics discovery, development, and manufacturing to benefit patients worldwide. Our global sites include China, the US, the EU, and Asia, employing over 10,000 people and supporting more than 600 customers, including the top 20 biopharma companies.
Department Description
As a QC Operations Scientist, you will join a diverse team committed to impactful work, reporting to the QC Operations Senior Scientist.
Essential Duties and Responsibilities
* Ensure safe startup and routine operations of the QC laboratory.
* Support facility qualification and process validation activities.
* Develop and maintain quality systems to ensure cGLP compliance.
* Manage samples from manufacturing and client sites using LIMS.
* Coordinate shipment of samples to testing sites.
* Maintain inventory and stock records in LIMS.
* Create training materials for QC personnel.
* Lead or support QC test method validation and routine testing strategies.
* Perform additional duties as assigned by the manager.
* Monitor laboratory KPIs, control stock of consumables, and support expansion projects.
* Assist in investigations of OOS, OOL, and other deviations, including CAPAs.
* Author and review technical documents, SOPs, and protocols.
* Support risk assessments and continuous improvement initiatives.
* Stay updated on regulatory trends affecting laboratory operations.
* Coordinate project activities, including client communications.
* Prepare for and manage regulatory inspections and audits.
* Participate in internal and external QC audits.
* Train team members and manufacturing staff on laboratory methods.
* Ensure all activities comply with GMP, SOPs, and regulatory standards.
* Act as a role model for quality and compliance within the organization.
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