QA Investigation Specialist

Role Summary

QA Investigation Specialist position within the Bulk Drug Substance Manufacturing Quality Assurance team. The role performs compliance-related tasks to complete investigations and implement robust corrective actions in support of manufacturing operations. Responsibilities include investigating non-conformances, preparing investigation reports with recommendations, and collaborating with cross-functional teams to drive corrective actions.

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

• Required: Bachelor’s degree in Life Sciences, Engineering, or related field; Associate Specialist – 0-2 years; Specialist – 2+ years; Senior Specialist – 5+ years. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
• Preferred: Excel in a quality driven organization
• Preferred: Have an understanding of biologics manufacturing operations
• Preferred: Are organized and have an attention to detail
• Preferred: Can prioritize multiple assignments and changing priorities
• Preferred: Are able to learn and utilize computerized systems for daily performance of tasks

Education

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