Stability Analyst

4 weeks ago

South Derbyshire Derbyshire, United Kingdom Kenton Black Full time

Job Title: Stability Analyst Location: Derbyshire Salary: 26-32K D.O.E My client are dedicated to excellence in pharmaceutical testing and research. We uphold the highest standards in cGMP/GLP compliance and are seeking a meticulous and proactive Stability Analyst to join our Validation and Stability team. If you are a recent chemistry graduate with a year in industry – I want to speak to you Key Responsibilities:

  • Conduct analytical testing according to cGMP/GLP, SOPs, and Work Instructions, with a focus on QC analytical project testing and stability testing.
  • Assist with the stability program, including generating protocols, reports, trial discontinuation, and stability data tables.
  • Initiate stability trials and maintain stability program product trending.
  • Perform maintenance checks of stability cabinets and assist with laboratory documentation upkeep.
  • Act as a signatory for laboratory documentation, Work Instructions, and SOPs as an author or reviewer.
  • Advise senior staff on instrumentation and equipment deficiencies, proactively addressing potential delays or problems.
  • Troubleshoot analytical and equipment issues and investigate Out of Specification (OOS) results with line management assistance.
  • Carry out calibration tasks as delegated by the supervisor.
  • Ensure Validation & Stability Manager/QC Lab Manager are informed of any potential delays or problems.
  • Complete and review Stability Studies within required timeframes to meet business needs.
  • Escalate non-resolvable technical/quality issues to management.
  • Assist with training of laboratory staff and support other laboratory areas, including calibration and cleaning responsibilities.
  • Gain experience using HPLC, GC, or AA.
  • Maintain the laboratory to cGMP standards and ensure readiness for audits.
  • Provide support in executing validation tasks and project paperwork.
  • Perform other tasks as assigned by the Validation & Stability Manager.
Qualifications:
  • Degree in Chemistry, Biochemistry, or related field.
  • Experience in analytical testing within a cGMP/GLP environment.
  • Strong understanding of stability testing and quality control procedures.
  • Proficiency with laboratory instrumentation and troubleshooting techniques.
  • Excellent documentation and communication skills.
  • Ability to work collaboratively in a team and independently manage tasks.
  • Experience with HPLC, GC, or AA is a plus

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