Expected Start Date: June 2025 (Will begin interview process in May)
6 Month Contract
Norwood, MA
PR: $80-87/hour
Job Responsibilities
- Develop / revise documents (SOP, test methods, specifications, etc).
- Author for CAPA, deviations, and OOS investigations
- Performs general laboratory support activities
- Support and own various quality system records such as deviations, change controls, CAPAs, and OOS / OOT investigations for cGMP Quality Control
- Author Chemistry, Bioassay, Microbiology lab investigations / deviations as well as investigations for QC lab support functions
- Assist with compiling metrics / KPIs for trending analysis
- Support the authoring and revision of equipment, method, and other laboratory procedures and reports
- Complete and maintain cGMP documentation (electronic and hard copy) for work performed
- Work with Quality Assurance to close records in a timely manner
- Assist in process improvement projects within multi-disciplined teams
Education & Qualifications
- BS (min) , MS, or PhD (experience is more important than education).
- 8-10 years handling investigations and working in a GMP environment