Senior Quality Control Specialist
2 weeks ago
Job Summary
At Autolus Limited, we are seeking a highly skilled Senior Quality Control Specialist to join our team. As a key member of our Quality Control Operations department, you will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans.
Key Responsibilities
- Execution of analytical tests - in process drug product samples
- Execution of analytical tests - release drug product samples (all assays)
- Execution of analytical tests - drug product stability samples
- Execution of analytical tests - vector testing
- Laboratory housekeeping - maintenance of laboratory in inspection ready state
- Reagent preparation (e.g., preparation of media, aliquots, controls)
- Management of QC materials (e.g., media preparation, aliquoting, stock management)
- Operation and maintenance of analytical instruments in accordance to governing SOPs
- Participation in execution of qualification scripts (IOPQ)
- Preparation of User Requirement Specifications for new instruments
- Conducting complex root cause analysis using appropriate tools
- Initiation of deviation, laboratory investigation, change control or CAPA as required
- Performing impact assessment for major deviations and major change controls
- Leading internal QC investigations forming part of deviation, laboratory investigation
- Defining and implementing effective CAPA within QC and across multiple functions
- Ownership of major internal QC change controls
- Acting as SME in change control process
- Performing risk assessments for internal QC procedures and processes
- Data entry / collation for tracking and trending purposes
- Review and approval of QC records
- Preparation of calculating spreadsheets following guidelines
- Design of data trending / tracking approaches
- Archiving of GMP records
- Completion of GMP documentation in accordance with ALCOA/data integrity requirements
- Designing GMP documentation (e.g., logbooks, forms)
- Managing GMP documentation (logbooks, worksheets, documentation trackers)
- Timely completion of own quality events
- Designing worksheets
- Preparation of high quality SOPs using approved templates (general QC procedures and analytical methods)
- Preparation / review of certificate of analysis
- Review and approval of SOPs / spreadsheets
- When required acting as shift supervisor
- Managing batch certification activities
- Implementation of QC processes / systems
- Approval of certificates of analysis
- Execution of tech transfer, validation / verification of analytical methods
- Preparation of tech transfer / validation / verification protocols
- Participation in preparation of tech transfer, validation / verification reports
- Any other duties as required following consultation with the post holder
- Work in adherence to local Health and Safety policies and SOPs
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