Lead Specialist, QA Investigations

Job Description

Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Senior Specialist to join there tenured QC team.

Key responsibilities for this role include:

• 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.

The minimum qualifications for this role are:

• 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.