Senior Quality Control Specialist
6 days ago
We are seeking a highly skilled Senior QC Scientist to join our Quality Control Operations team at Autolus Limited. As a key member of our team, 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 for in-process drug product samples, release drug product samples, and drug product stability samples
- Execution of analytical tests for vector testing and laboratory housekeeping
- Reagent preparation, management of QC materials, and operation and maintenance of analytical instruments
- Participation in execution of qualification scripts and preparation of User Requirement Specifications for new instruments
- Conducting complex root cause analysis and initiation of deviation, laboratory investigation, change control, or CAPA as required
- Leading internal QC investigations and defining and implementing effective CAPA within QC and across multiple functions
- Ownership of major internal QC change controls and acting as SME in change control process
- Performing risk assessments for internal QC procedures and processes and data entry/collation for tracking and trending purposes
- Review and approval of QC records and preparation of calculating spreadsheets following guidelines
- Design of data trending/tracking approaches and archiving of GMP records
- Completion of GMP documentation in accordance with ALCOA/data integrity requirements and design of GMP documentation
- Managing GMP documentation and timely completion of own quality events
- Designing worksheets and preparation of high-quality SOPs using approved templates
- Preparation/review of certificate of analysis and review/approval of SOPs/spreadsheets
- Acting as shift supervisor and managing batch certification activities
- Implementation of QC processes/systems and approval of certificates of analysis
- Execution of tech transfer, validation/verification of analytical methods and preparation of tech transfer/validation/verification protocols
- Participation in preparation of tech transfer/validation/verification reports
- Minimum 8 years' experience within a QC laboratory, without a BSc/MSc degree or
- Minimum 5 years' experience within a QC laboratory, with a BSc/MSC degree or
- Minimum 2 years' experience within a QC laboratory, with a PhD in life sciences or relevant subject
- BSc/MSc degree in life sciences or significant relevant industry experience
- Soft skills (effective written and spoken communication, organisation, teamwork)
- Ability to precisely follow instructions and procedures
- Open to working shifts
- Attention to detail
- Meet requirements to work in cleanroom environment
- Expert technical writing and data presentation skills using multiple tools
- Ability to prepare complex calculating spreadsheets, large documents, and presentations
- Understanding of biostatistics applied in Quality Control
- Reporting of numerical values – significant figures, decimal places, rounding in the context of generating and reporting results
- Understanding of method performance parameters
- Working knowledge of analytical method lifecycle, validation, tech transfer designs
- Working knowledge of relevant regulations governing Quality Control function
- Working knowledge of Quality Management System records
- Expert knowledge of aseptic technique and cell culture methodology
- SME knowledge in complex analytical instruments
- Familiarity with relevant sections of regulatory dossier
- Technical expertise at least one of the assay platforms
- Understanding of stability/shelf-life management for pharmaceutical products
- Experience in LIMS
- Experience of training, mentoring, and supervision of junior laboratory staff
- Experience leading cross-functional projects
- Technical expertise of analytical aspects of analytics of biologics
- Working knowledge of biostatistics/Trend
- Good level of understanding of GMP quality system
- Minimum of 3 years' experience in a GMP laboratory
- Experience in leading investigations for OOS/QERs/Change controls
- Experience in authoring GxP documentation
- Technical Expert in at least one of the following and understanding knowledge of:
- Manufacturing process
- Assay knowledge
- QC instrumentation
- Data analysis skills
- Understanding of regulatory guidelines around technology transfer and validation
- Stability and shelf life
- Proficient user of Office 365 tools
- Excellent understanding of GMP regulations
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob SummaryAutolus Limited is 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 ResponsibilitiesExecute analytical tests...
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob SummaryAutolus Limited is 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 ResponsibilitiesExecute analytical tests...
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob SummaryAutolus Limited is seeking a highly skilled Senior QC Scientist to join our Quality Control Operations team. As a key member of our team, you will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans.Key ResponsibilitiesExecution of analytical tests for in-process...
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob SummaryAutolus Limited is seeking a highly skilled Senior QC Scientist to join our Quality Control Operations team. As a key member of our team, you will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans.Key ResponsibilitiesExecution of analytical tests for in-process...
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time{"Role Summary": "At Autolus Limited, we are seeking a highly skilled Quality Control Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our raw materials and products.Your primary focus will be on inspecting and testing incoming materials, maintaining detailed records, and collaborating with...
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Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time{"Role Summary": "At Autolus Limited, we are seeking a highly skilled Quality Control Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our raw materials and products.Your primary focus will be on inspecting and testing incoming materials, maintaining detailed records, and collaborating with...
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