Investigation Specialist

Investigation Specialist

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 0-2+ years of relevant experience for Associate Specialist
• 2+ years of relevant experience for Specialist
• 5+ years of relevant experience for Senior Specialist
• Proven experience may substitute for education requirement

Responsibilities

• Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
• Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
• Communicating findings and recommendations at group meetings
• Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
• Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
• Participating in and/or leading cross-functional study teams to get results, support and or author investigations
• Gathering, trending, and analyzing process related data to drive consistency and timeliness
• Documenting all training
• Training new employees on investigative processes and techniques
• Coordinating and/or leading cross-functional meetings with multiple departments.

Preferred Qualifications

• Excel in a quality driven organization
• Understanding of biologics manufacturing operations
• Organized and have attention to detail
• Can prioritize multiple assignments and changing priorities
• Able to learn and utilize computerized systems for daily performance of tasks