Oxford Immunotec, Inc.

Senior Quality Control Scientist

Job Location UK-Milton Park, Abindgon
Posted Date 1 month ago(10/22/2020 10:42 AM)
ID
2020-2125
# of Openings
1
Department
Quality & Regulatory

Overview

This position is a key role in the Quality team in the QC of raw materials and finished product, conduct of stability and validation studies, and general administration of documentation for the QMS. The position is responsible for the planning and execution of project lab work including stability studies and planning and execution of cell culture required to support these studies.

Responsibilities

  • Plan, in conjunction with Quality Operations Manager, activities within QC for the testing of raw materials used for manufacturing and QC, including:
  • o    Incoming QC of items requiring CofA/packaging checks
  • o    Laboratory testing of manufacturing components.
  • Plan, in conjunction with Quality Operations Manager and when necessary conduct, QC testing of final manufactured product and assembled kits.
  • The planning of the conduct of stability and archive testing procedures using the T-SPOT® assay including the plan and report writing and associated risk assessments, as required.
  • Attend company project meetings where appropriate.
  • Be responsible for the conduct of complaint testing.
  • Plan and execute the cell culture of polyclonal cell lines using aseptic techniques.
  • Plan the conduct of validation for procedures, processes and equipment.
  • Conduct of Risk Assessments.
  • Assisting with the monitoring of compliance with the QMS and with tracking systems associated with ISO 13485:2016 and ISO 17025:2017 and MDSAP requirements.
  • Assist the Director, Quality to ensure the continuing effectiveness of the QMS.
  • To support the Director, Quality during internal and external audits as required.
  • Additional support for QA functions as necessary
  • Perform miscellaneous duties as necessary.

 

Specific deliverables for the role are:

  • Contributing towards the maintenance of the quality of OI products in fulfillment of OI’s Company goals.
  • Monitoring of product conformity through incoming and finished product QC, archive kit and stability testing.
  • Assisting with ensuring compliance in the manufacturing process and documentation.
  • Ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GMP, ISO 13485:2016 and ISO 17025:2017
  • Working to Oxford Immunotec’s Company Values at all times.

Qualifications

Technical skills and abilities

  • Educated to degree level in a relevant subject or with relevant technical/practical experience.
  • Experience of ISO 13485 is essential.
  • Ideally previous line management or supervisory experience.
  • General use of computers with MS programs and the Internet.
  • Experienced in working to GLP and Quality Management principles. 

 

Emotional skills and abilities

  • Pleasant disposition with a co-operative attitude.
  • Energetic and enthusiastic.
  • 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.

Competence Level

Professional Level

  • Customer Focus.
  • Team Work.
  • Displaying Personal Leadership.
  • Remembering Work is about People.

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