Quality Assurance Specialist

1 week ago

Abingdon, Oxfordshire, United Kingdom Revvity Full time
Job Description

Job Summary:

The Quality Technician will support the Quality team in the release of raw materials and finished product, general administration for the Quality Management System (QMS), and aid the release of Laboratory Operations service results.

Key Responsibilities:
  • Quality Control: Perform the Quality Control of raw materials used in the Manufacturing process, including inspection and release of items requiring Certificate of Analysis (CofA)/packaging checks, and laboratory testing and release of kit components using the T-SPOT assay platform.
  • Quality Assurance: Assist with Quality Assurance review and control of QMS documentation, including appropriate handling and storage of documentation, physically and electronically using OI's Enterprise Resource Planning (ERP) system, and assisting with Non-Conformance Report (NCR) and Corrective Action Preventive Action (CAPA) investigations, as required.
  • Manufacturing Support: Perform critical activities to support Manufacturing in product release, including in-process Quality checks of Manufacturing operations, review and approval of kit and kit component labels, review and approval of Manufacturing batch records for labeling and assembly operations, review of documentation for the heat treatment and sterilization of consumables critical for the manufacturing process, review of bioburden certificates, including investigation of out-of-specification results, and creation of product CofAs.
  • Laboratory Maintenance: Perform general laboratory maintenance, including cleaning of laboratory equipment and maintenance of cleaning records, preparation of media aliquots, and verification of non-critical laboratory equipment, e.g., internal pipette verification.
  • Compliance and Monitoring: QC of patient test results from the Laboratory Operations testing service under ISO 17025:2017/GCP requirements, and assist with the monitoring of compliance with the QMS and with tracking systems associated with ISO 13485:2016 and ISO 17025:2017 and the Quality System Regulation (QSR).
Requirements:
  • Education: Educated to degree in a relevant scientific subject or with relevant technical/practical experience.
  • Technical Skills: General use of computers with MS programs and the Internet.
  • Emotional Skills: Pleasant disposition with a co-operative attitude, attention to detail and Quality 'mindset', high standard of numeracy and literacy, conscientious, able to work under pressure, work well alone and as part of a team, and works carefully to get things right the first time and identifies non-compliance.
  • Competence Level: Foundation Level, including Compliance & Integrity, Customer Focus, Personal Learning, Accountability, Building Effective Teams, Working to a common goal, Communication & Relationships, Perseverance, and Creativity & Innovation.

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