Quality Control (QC) Investigator

Job Title: Quality Control (QC) Investigator100% onsite in Norwood MAConsidering multiple levels of experience ($80 an hour)ResponsibilitiesThe QC Investigator will focus on managing and resolving quality system records and supporting cGMP compliance. Key responsibilities include:Quality System RecordsOwn and support quality records such as deviations, CAPAs, change controls, and OOS/OOT investigations for cGMP Quality Control.Investigation AuthoringConduct investigations and author reports for Chemistry, Bioassay, and Microbiology laboratory issues.Document findings and root causes in accordance with cGMP standards.Data AnalysisCompile and analyze metrics and KPIs for trending and process improvement.Documentation ManagementAuthor, review, and maintain equipment, methods, and laboratory procedure reports.Complete and manage cGMP documentation (both electronic and hard copy).Cross-functional CollaborationPartner with Quality Assurance to close records in a timely and compliant manner.Contribute to multi-disciplinary team initiatives for process improvement.Process ImprovementAssist in identifying opportunities to enhance quality and efficiency within QC operations.EducationMinimum BS in a scientific discipline8-10 years of experience of industry experience handling investigations

Created: 2025-02-04