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QC Officer IV, Stability - Analytical Services Group

OXB-ASG-19-043b
Competitive
Permanent
35 / per week - Full-Time
Cowley ,
Oxford

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 IV 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:

  • Writing and reviewing of SOPs and documentation related to QCO activities
  • Able to assist with trouble shooting QCO related issues
  • Coordinate stability studies so they are are planned, performed within the time point window and reports QC checked in a timely manner
  • QC checking of stability reports is essential
  • QC Checking of submission forms for external testing (inet), QC check reports and report data in COA / COT and create purchase orders.
  • Coordinate and arrange outgoing shipments to external testing facilities
  • Track and monitor departmental quality records and report metrics
  • Be a trainer for the team in multiple processes/procedures
  • Draft SOPs and provide / technical input where relevant.
  • Manage and oversee a QCO processes
  • Provide analytical and stability updates to customers (internal / external)
  • Input into validation of analytical spreadsheets
  • Generate and issue stability plans, protocols and reports at each time point
  • QC issuing assay forms for Scientists
  • Performing trend analysis of assay controls and standards
  • Create, manage and QC check stability trackers
  • Generation of batch specific COA and COT and QC Database
  • Updating product specifications
  • Reporting data to customers (Statement of Results or Analytical Update)
  • Calculation checks for QC Release assays
  • QC Checking of non-technical assays
  • QC Checking of stability reports
  • Generations of monthly metrics for HOD
  • Management of departmental Quality Records
  • Management of external testing and reporting and liaising with external testing labs as first point of contact for any queries
  • Validation of analytical spreadsheets

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)
  • Detailed understanding and ability to uphold / improve GMP compliance for ASG processes and procedures.
  • Ability to uphold / improve the quality management and reporting structure at OXB
  • Able to communicate both internally and externally
  • Be able to give presentations of work within the Company
  • Able to effectively communicate clearly and concisely at internal meetings
  • Understand the activities, goals and objectives for the department and to be able to contribute useful ideas at meetings 

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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