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Viatris · 9 hours ago

Lead Specialist QA Investigations, QA, 1st shift

St Albans, VT

Full-time

Onsite

Mid, Senior Level

$66K/yr - $127K/yr

4+ years exp

Viatris is a company focused on empowering people worldwide to live healthier at every stage of life. The Lead Specialist QA Investigations role involves leading complex investigations, mentoring QA specialists, and ensuring compliance with quality standards through effective problem-solving and continuous improvement initiatives.

BiotechnologyHealth CareLife SciencePharmaceutical

Responsibilities

Lead critical / complex investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports

Lead / participate in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact

Provides mentorship and supports training/development of QA Specialist Investigators

Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required. Prepare and/or approve associated reports

Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA

Leads periodic and special cause trending assessments to determine corrective actions to address trends. Prepare periodic reports as assigned

Leads continuous improvement project teams, as well as owns and executes department CAPA as assigned. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion

Authors new or revised site procedures as assigned. Prepares and provides training related to investigations, site procedures and cGMP as assigned

Approves laboratory investigations, incidents, and investigations as authorized

Qualification

CGMPQuality SystemsRoot cause analysisStatistical AnalysisTechnical WritingCommunication Skills

Required

Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration

Must possess a working knowledge of cGMP, Quality Systems, and root cause analysis techniques

Must understand the cGMP standards for the investigation of non-conformances and the contents of investigation reports

Ability to add, subtract, multiply and divide

Statistical Analysis, Advanced Mathematical calculations

Must possess strong communication skills (written and verbal)

Must have experience in technical writing