Senior Quality Control Scientist

7 hours ago

Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time
Job Title: Senior QC Scientist, QC Operations

At Autolus Limited, we are seeking a highly skilled and experienced Senior QC Scientist to join our Quality Control Operations team. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products, from raw materials to finished goods.

Key Responsibilities:
  • Execution of analytical tests for in-process drug product samples, release drug product samples, drug product stability samples, and vector testing.
  • Laboratory housekeeping, including maintenance of the laboratory in an inspection-ready state.
  • Reagent preparation, management of QC materials, and operation and maintenance of analytical instruments.
  • Participation in the execution of qualification scripts, preparation of user requirement specifications for new instruments, and conducting complex root cause analysis.
  • Initiation of deviation, laboratory investigation, change control, or CAPA as required.
  • Performing impact assessments for major deviations and change controls, leading internal QC investigations, and defining and implementing effective CAPA within QC and across multiple functions.
  • Ownership of major internal QC change controls, acting as SME in the change control process, and performing risk assessments for internal QC procedures and processes.
  • Data entry, collation, and tracking for trending purposes, review and approval of QC records, and preparation of calculating spreadsheets.
  • Design of data trending and tracking approaches, archiving of GMP records, and completion of GMP documentation in accordance with ALCOA/data integrity requirements.
  • Designing GMP documentation, managing GMP documentation, and timely completion of own quality events.
  • Preparation of high-quality SOPs, review and approval of SOPs and spreadsheets, and acting as shift supervisor when required.
  • Managing batch certification activities, implementation of QC processes and systems, and approval of certificates of analysis.
  • Execution of tech transfer, validation, and verification of analytical methods, preparation of tech transfer and validation protocols, and participation in the preparation of tech transfer and validation reports.
Requirements:
  • 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, including effective written and spoken communication, organization, teamwork, ability to precisely follow instructions and procedures, open to working shifts, attention to detail, and meeting requirements to work in a 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, and reporting of numerical values.
  • Working knowledge of analytical method lifecycle, validation, tech transfer designs, relevant regulations governing Quality Control function, Quality Management System records, aseptic technique and cell culture methodology, complex analytical instruments, and relevant sections of regulatory dossier.
  • Technical expertise at least one of the assay platforms, SME knowledge in complex analytical instruments, familiarity with relevant sections of regulatory dossier, and proficiency in Office 365 tools.
What We Offer:

At Autolus Limited, we offer a competitive salary and benefits package, opportunities for professional growth and development, and a dynamic and supportive work environment.

We are an equal opportunities employer and welcome applications from diverse candidates.

Please submit your application, including your CV and a cover letter, to [insert contact information].

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