QC Stability Specialist

Job description

QC Stability Reviewer


Job Responsibilities:

  • Review analytical release and stability data that has been generated within the department

  • Critically review raw data and liaise with other departments

  • Review of data generated for pre-formulation activities

  • Perform laboratory investigations to resolve non-conforming data or out of trend data and liaising with clients on any non-conformances

  • Compile formal stability reports including Time-Point and End of Study reports

  • Assist Stability Centre Team Leader with management of stability programmes

  • Formulating weekly work schedules with support from Stability Centre Team Leader

  • Reviewing analytical documentation and ensuring Right First Time KPIs are achieved

  • Trending of finished product results

  • Maintaining laboratory SOPs and specifications in a state of compliance


    Key Job Requirements:

  • At least 3-5 years' experience working within a cGMP environment (HPRA and FDA approved). 

  •  2 years of bench work and 1 year stability within a QC laboratory
  • A BSc in a related discipline is a must.

  • Extensive experience with HPLC,  GC is required with a minimum of one years Stability review experience

  • Ability to advise and lead a small team of analysts.

  • Ability to trouble shoot, identify analytical issues and follow up with corrective actions.

If you think you meet the criteria for this job contact Clara on 01 4744676 or email

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