Quality Assurance Specialist

3 weeks ago

Abingdon, Oxfordshire, United Kingdom Revvity Full time
Job Title: Quality Technician

This role supports the Quality team in the release of raw materials and finished product, general administration for the Quality Management System (QMS), and aids the release of Laboratory Operations service results.

Key Responsibilities:
  • Performing the Quality Control (QC) 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.
  • Assisting with Quality Assurance (QA) 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.
  • Performing 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.
  • Performing general laboratory maintenance, such as 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.
  • QC of patient test results from the Laboratory Operations testing service under ISO 17025:2017/GCP requirements.
  • Assisting 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).
  • Assist the Director, Quality to ensure the continuing effectiveness of the QMS.
  • Perform miscellaneous duties as necessary, such as updates of QMS documentation following the Document Control process using the eQMS, maintaining and disposing of Quality stock, ensuring the department is audit-ready at all times, control and movement of stock, both physically and electronically using OI's ERP system.
Deliverables:
  • Monitoring of product conformity through incoming QC.
  • Collaborate and assist to ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GCP, GMP, MDSAP, ISO 13485:2016, and ISO 17025:2017.
  • Contributing towards the maintenance of the quality of products in fulfillment of Company goals.
  • Working to Revvity's Company Values at all times.
Requirements:
  • Educated to degree in a relevant scientific subject or with relevant technical/practical experience.
  • General use of computers with MS programs and the Internet.
  • 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.
  • Works carefully to get things right the first time and identifies non-compliance.
Competence Level:
  • Foundation Level.
  • Compliance & Integrity.
  • Customer Focus.
  • Personal Learning.
  • Accountability.
  • Building Effective Teams.
  • Working to a common goal.
  • Communication & Relationships.
  • Perseverance.
  • Creativity & Innovation.
What We Offer:
  • Purposeful & inclusive work environment.
  • Dynamic culture in which customers are at the forefront.
  • Being part of a highly qualified team that is committed to excellence.
  • Access to cutting-edge expertise through which you can make positive impact in the world around us.

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