Stability Analyst
4 months 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.
- 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