Investigation Specialist (Technical Operations)

Role Summary

We are currently looking to fill an Investigation Specialist position supporting our Technical Operations team. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.

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

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (required)
• Experience levels by role: Associate Specialist – 0-2+ years; Specialist – 2+ years; Senior Specialist – 5+ years (level determined by qualifications relevant to the role)
• May substitute proven experience for education requirements

Skills

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

Education

• Bachelor’s degree in Life Sciences, Engineering, or related field

Additional Requirements

• On-site work may be required; discuss with the recruiter/hiring manager for policy and location expectations