Oxford BioMedica (UK) Limited

QC Officer, Translational Sciences Group

Location
Oxfordshire
Salary
Competitive
Posted
06 Apr 2021
Closes
04 May 2021
Ref
OXB-TSG-21-042
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

Oxford Biomedica’s Translational Sciences Group is responsible for supporting and optimising the development of internal and external therapeutic products through preclinical and clinical research, utilising high quality bioanalytical assays to provide a detailed understanding of safety and efficacy parameters

We are currently recruiting for a QC Officer to join the team.  The purpose of this role is to have responsibility for overseeing and improving all GxP-compliant processes and facilities within TSG. The individual will play a key part in external Regulatory GLP and GCP(Labs) inspections and will ensure the timely reporting of analytical data to Study Directors and Analytical Project Managers. Provide oversight of TSG compliance including effective management of Quality Systems, production of quality metrics and continuous improvement of TSG processes in line with GxP requirements. 

Your responsibilities in this role would be:

Quality Records and Training

  • Create, manage and maintain Departmental Quality Control trackers and report metrics to Head of Dept
  • Raise and manage Departmental quality records (Deviations/Change Control/CAPA) and be responsible for ensuring that documents are progressed as per required timelines
  • Assist in generation of OJT and Departmental training plans
  • Be a trainer for the team in multiple processes/procedures
  • Writing and reviewing of Standard Operating Procedures and documentation related to Quality Systems relevant to TSG activities
  • QC Checking of equipment monitoring and maintenance forms
  • Prepare study documentation for archiving and approval by SD/PI/APM
  • Archiving of equipment maintenance, monitoring, reagent preparation forms, equipment files, training records and any relevant GxP supporting documentation
  • Calculation checks for GxP assays
  • Assist SDs/PIs/APMs in the management of assays, generation of equipment validation documents and the validation of analytical spreadsheets
  • Liaise regularly with QA Analytics, Validation and Compliance to ensure that TSG maintain compliance and TSG are involved with continuous improvements and receive training accordingly

 Reagent / Assay Performance

  • Manage stability studies so that they are performed within the time point window and reports are QC checked in a timely manner and reported to internal / external stakeholders as required
  • Performing trend analysis of assay controls and standards including the collation of metrics leading to assay improvement and optimisation
  • QC checking of stability reports
  • Creation and maintenance of reagent stability databases

To be successful in this role, you will have the following skills and experience:

  • Science Graduate with biological background or experience working within a pharmaceutical or clinical regulated environment
  • Extensive experience of working in a GxP-compliant environment, particularly GLP
  • Knowledge of performing analytics within a GxP environment
  • Computer literate (MS Word, MS Excel)
  • Ability to uphold / improve the Quality Management and reporting structure within TSG
  • Able to communicate effectively both internally and externally
  • Good interpersonal and communication skills (written and verbal)
  • Highly organised and motivated with excellent attention to detail
  • Ability to work independently as well as in a team setting
  • Problem solving skills and ability to make informed decisions
  • Self-motivated and able to motivate others
  • Excellent time management skills

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No agencies please

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