QA Investigation Specialist
Core
Investigating non-conformances, analyzing process data, and implementing corrective actions to support biologics manufacturing operations.
Role type
Quality Assurance Investigation Specialist
Builds
Compliance reports and corrective action plans for manufacturing operations
Domain
Biologics manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
cGMP compliance, root cause analysis, data trending, batch record review, SOP management, cross-functional collaboration, cleanroom gowning procedures
Preferred skills
biologics manufacturing knowledge, computerized systems proficiency, training delivery
Technologies
Computerized systems for daily performance
Responsibilities
Investigate non-conformances and prevent reoccurrences, prepare investigation reports with recommendations, analyze and summarize investigation data trends, review batch records and logbooks per cGMP standards, edit and revise controlled documents, monitor production processes for data acquisition, lead cross-functional study teams, document training, train new employees on investigative processes
Seniority
Specialist (2+ years experience) to Senior Specialist (5+ years experience)
