Quality Specialist Investigator - Kelly Services : Job Details

The Quality System Lead will be responsible for reviewing and overseeing various validation and qualification documentation, including but not limited to, Process Validation, Cleaning Validation, Computer Validation, Equipment/ Utilities Qualification, Commissioning, and Method Validation. The role involves reviewing key documentation such as Validation Master Plans, protocols, reports, design qualifications, risk assessments, traceability matrices, user requirement specifications, software/hardware design specifications, factory acceptance testing, engineering studies, media fills, smoke studies, site acceptance testing, system component criticality reviews, and protocol deviations related to new products, equipment, and systems. Additional responsibilities include but are not limited to: Quality review and approval of Change Controls, Investigations, and CAPAs. Preparation and review of Annual Product Reports (AP - Rs). Participation in internal and external cGMP audits. Preparation,...Investigator, Specialist, Quality, Validation, Microbiology, QA, Technology, Staffing