The Role & What You Will Be Doing
The Quality Control (QC) Analyst III will be primarily responsible for the advanced chromatographic and wet chemistry analysis of raw materials, in-process, finished product and stability product samples and completing the relevant GMP documentation.
Conduct routine chromatographic (HPLC and GC, but primarily HPLC) and wet chemistry testing of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures.
Assist in the transfer (and troubleshooting, where required) of analytical methods to the QC laboratory as and when required.
Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in a timely manner.
Ensure OOS results are escalated and where relevant FARs are required they are initiated within the required timeline.
Assist in chromatography and wet chemistry training of other QC analysts.
Review and approve non-chromatographic and chromatographic data.
Present as subject matter expert during third party inspections as required.
Support continuous improvement projects such as 6S and lean processes for the laboratory.
Management of QC SOPs, change controls, deviations and IRFs.
Conduct calibration and maintenance of wet chemistry/chromatography instrumentation.
Participate in department projects, as assigned by QC Team Leader/QC Manager.
About Your Skills & Experience
Minimum of a Bachelor's degree (or equivalent) in a Science related discipline (Chemistry, Biochemistry or Analytical science) and 5+ years of relevant industrial experience.
Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential.
Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.
Strong technical writing skills.
Experience with Empower and other lab software systems.
cGMP computer skills (MS Office, Trackwise, Minitab, LIMS).
College level mathematics ability.
Ability to solve practical problems through standardized solutions that require limited judgment.
Ability to follow prescribed and detailed procedures to solve routine problems.
Benefits at Viatris
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.
You may just be the right candidate for this or other roles.
Viatris is an Equal Opportunity Employer.
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