Lead Specialist, QA Investigations Job at Germer International - Pharmaceutical Recruiting, Burlington, VT

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  • Germer International - Pharmaceutical Recruiting
  • Burlington, VT

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.

Job Tags

Local area,

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