Compliance Scientist

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Closing date
24 Sep 2020
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Our employees are able to develop their careers in exciting new medical technologies, and so can you.

Oxford BioMedica’s Analytical Services Group supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.

We are currently recruiting for a Compliance Scientist to join the team.  The purpose of this role is to maintain a high quality of analytical data and provide compliance support to the analytical team, effective management of quality records  and continuous improvement of ASG processes in line with GxP requirements

Your responsibilities in this role would be:

  • Report writing of laboratory investigations
  • QC Checking of assay data in QC databases for data integrity.  Such as ELISA, Tissue culture, and qPCR
  • QC Checking of assays and equipment maintenance forms
  • Raising and completion of quality records (Deviations/Change Control/CAPA) in the time frame stipulated on relevant SOPs
  • Involved in internal audits and ensuring actions form findings are performed on time
  • Aid with set-up and management of tools that facilitates the smooth running routine QC tests
  • Assist laboratory scientists with laboratory tasks when required with the supervision of more senior scientists.
  • Management of assays through QA review to completion.
  • Assist with the progression of departmental quality records in agreed timelines.
  • Management of self-inspections within the department, report findings and complete actions (where necessary).
  • Generating reports for customers (Statement of Results or Analytical Update)
  • Calculation checks for QC Release assays
  • QC checking of non-technical assays
  • Monitoring monthly metrics to ensure the team maintains a high level of quality

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

  • Experience working within a pharmaceutical regulated environment is essential, having obtained a relevant degree
  • Understanding of GxP regulations is essential
  • Understanding of the Quality Management System reporting structure and responsibilities within OXB
  • Knowledge of QC testing within a GMP environment is essential
  • Computer literate (word, excel, MS Office)
  • Involved in internal audits and ensuring actions form findings are performed on time
  • Knowledge of writing concise quality records
  • To support the implementation of any process improvements within ASG
  • Have a questioning attitude to embed understanding.
  • Problem-solving skills to help identify a way forward when issues arise

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

About us

We are a pioneering gene therapy business, and our mission is delivering life-changing gene therapies to patients.  We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it; long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world-leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene-based medicines, both in-house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Contact Us
  • Windrush Court
  • Transport Way
  • OX4 6LT
  • United Kingdom
  • +44 (0) 1865 783 000
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