Quality Control Officer 2 (Stability)
- Experience Level
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 (stability) 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
- 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.
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