Senior Specialist QC Investigations – 1st Shift

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:

• Leads investigations of incidents, aberrant results, and trends. Propose associated CAPA actions and prepare associated investigation reports.
• Interacts with QC department personnel and cross functional teams in support of investigations.
• Prepare periodic reports as assigned.
• Compile and analyze investigation information. Present to local and vertical leadership as required.
• Supports and executes department CAPA as assigned.
• Leads periodic and special cause trending assessments to determine corrective actions to address trends.
• Supports continuous improvement project teams and help propose strategies and tactics for accomplishing objectives.
• Authors quality documentation including SOPs, specifications, STMs, and change controls.
• Assists in preparing documentation supporting regulatory submission of post approval changes.
• Participate on project teams as assigned.
• Prepares and provides training related to investigations, site procedures, and cGMP as assigned. Provides training of laboratory personnel in aspects of the laboratory quality system.

The minimum qualifications for this role are:

• Minimum of a bachelor’s degree (or equivalent), 4+ years of relevant experience, and a fundamental understanding of Quality Systems, Quality Control laboratory, and cGMP. A combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of Pharmaceutical cGMP, Quality Systems, and analytical chemistry. Must understand the cGMP standards for the investigation of aberrant results and the contents of investigation reports.