QA Specialist I - Operations - (Bedford, NH)

JOB DETAILS Review all records associated with the manufacturing of a product lot for completeness and accuracy to ensure qualified specifications, parameters, and controls have been met and/or all deviations from such have been adequately and timely addressed. JOB ASSIGNMENTS Complete Executed Batch Record/protocol Review and supporting documentation with minimal to no supervision: Minor Deviations & supporting documentation Quality Control records Environmental Monitoring data CAPA documents and QA investigations Cleaning / Sterilization cycle records and testing Review protocol, study design and Master batch Records with direct to minimal supervision based on complexity Responsible for writing and revising Standard Operating Procedures, material control procedures, deviations, CAPA's, and Quality Investigations when applicable under direct to limited supervision Create / Revise documents using Microsoft office suite Review/approve minor system SOP updates