Quality Control Officer 2 (Compliance)
- Employer
- Oxford BioMedica (UK) Limited
- Location
- Oxfordshire
- Salary
- Competitive
- Start date
- 25 Feb 2021
- Closing date
- 25 Mar 2021
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 QC Officer 2 (compliance) to join the team. The purpose of this role is to ensure timely reporting of analytical data and provide oversight of ASG compliance, effective management of stability programs and continuous improvement of ASG processes in line with GxP requirements
Your responsibilities in this role would be:
- QC Issuing of ASG Documentation to ensure relevant paperwork is issued and controlled
- QC Checking of assay data in QC databases for data integrity
- QC Checking of equipment maintenance forms and non-technical assays
- Creation and maintenance of QC databases, CoA and COT’s required for batch release
- Ensure stability studies are set-up, performed within the time point window and reports written in a timely manner
- Set-up and management of QC Stability trackers
- Management of assays through QA review to completion.
- Draft submission forms for external testing (inet), QC Check reports and report data in COA / COT
- 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).
- Raise quality records (Deviations/Change Control/CAPA) and progress documents in a timely manner
- Prepare assay performance reports and product reviews
- Generate and issue stability plans, protocols and reports at each time point
- QC issuing assay forms for Scientists
- Performing trend analysis for assay controls and standards
- Create, manage and QC check stability trackers
- Generation of batch specific COA and COT and QC Databases
- Updating product specifications
- Generating reports for customers (Statement of Results or Analytical Update)
- Calculation checks for QC Release assays
- QC checking of non-technical assays
- Generation of monthly metrics for HOD
- Management of departmental Quality Records
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 regulated environment
- Knowledge of QC testing within a GMP environment
- Computer literate (word, excel, MS Office)
- To support the implementation of any process improvements within ASG
- Have a questioning attitude to embed understanding.
- Problem solving skills to help identify way forward when issues arise
- 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
- Self-motivated
- 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
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.com, www.oxbsolutions.com, and follow us on LinkedIn, Twitter 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.
- Website
- http://www.oxb.com/
- Telephone
- +44 (0) 1865 783 000
- Location
-
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom
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