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Compliance Scientist

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
27 Aug 2020
Closing date
24 Sep 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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
  • 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
  • Experience in ELISA, Tissue culture, and / or qPCR is a pre-requisite
  • 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

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

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.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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