Senior Quality Assurance Specialist

4 weeks ago


Abingdon, Oxfordshire, United Kingdom Hobson Prior Full time
Quality Control Scientist II Job Description

Hobson Prior is seeking a highly skilled Quality Control Scientist II to join our team in Abingdon. As a key member of our Quality Control Group, you will be responsible for managing quality records and ensuring readiness for inspections.

Key Responsibilities:
  • Oversee the timely completion of quality records in the Quality Control Group.
  • Participate in regulatory inspections and submissions, ensuring compliance with procedures.
  • Develop and implement protocols and reports for assay transfers/validation.
  • Review and complete documentation following Good Manufacturing Practices.
  • Write and review Standard Operating Procedures, forms, Deviations, Change controls CAPA, Certificate of Analysis reports.
  • Lead or assist with investigations as needed.
  • Introduce QC laboratory equipment and participate in validation activities.
  • Communicate QC requirements within and across other functional groups.
  • Perform QC testing following Standard Operating Procedures.
  • Assist with the maintenance of QC laboratory and equipment.
  • Manage receipt and storage of QC samples, reagents, and maintain retain inventory.
  • Coordinate shipping of samples to Milton Park and contract testing laboratories.
  • Train others within the department for methods and processes according to GMP standards.
  • Become a subject matter expert/trainer for method or process and lead troubleshooting or method optimization as required.
Requirements:
  • A degree in Chemistry/Biochemistry/Microbiology or other related science.
  • Experience in a GLP/GMP environment.
  • Computer literacy (including MS Word and Excel).
  • Ability to work well with others.
  • Effective communication skills.
  • Good organizational skills.


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