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Lead Specialist – QA Investigations
| Company | Viatris |
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| Location | Plattsburgh, NY, USA |
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| Salary | $66000 – $127000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level, Senior |
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Requirements
- 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.
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.
Preferred Qualifications
No preferred qualifications provided.
