Quality Control (QC) Inspector Job in Lexington, Massachusetts US
Quality Control (QC) Inspector
Senior Scientist, Quality Control The QC Senior Scientist provides expertise and technical leadership in support of the SMEs/Lab Managers for the management of deviations, investigations, Corrective and Preventative Actions (CAPA's), change requests, and improvement initiatives. As a lead investigator, the Senior Scientist will utilize their strong understanding of compliance and cGMP's to manage cross functional teams to drive investigation close out, determination of root cause and implementation of appropriate CAPA's. Creates and presents trending and metrics reports on deviations and corrective actions. Lead management of the document change requests for method SOPs ensuring accuracy and consistency. This position will provide project management support for the investigation of testing issues. The QC Senior Scientist will facilitate major investigations, review of change control requests, provide representation to tech transfer and CMC teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations. This position must demonstrate sound scientific judgment and leadership in decision-making while keeping open communications with all relevant technical areas, ensure that all work and deliverables are of high quality and on time. Must possess excellent communication skills and ability to work across departments and boundaries. The position must maintain a high level of technical expertise. 80%Routine project management and technical writing in support of including, but not limited to Investigations of in-process, DP and DS aberrant data and data trends. 10%Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers. 10%Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies. 7-10 years experience in pharmaceutical industry; experience in development of pharmaceutical and protein therapeutics, team leadership, and regulatory filings and inspections.