Quality Control Manager - West Greenwich, RI

, ATTENTION MILITARY AFFILIATED JOB SEEKERS, - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to, Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is 'On-Site' at the location detailed in the job post.Letâs do this. Letâs change the world. In this vital role you will be responsible for on-site management of Quality Control Bioanalytics team (Monday - Friday).Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP).The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.Additional Responsibilities:Coordinates the scheduling and execution of testing including routine analysis and testing in support of technology transfer for product within the Bioanalytics LaboratoriesProvides technical expertise/guidance to lab staff and within cross-functional Amgen teamsLeads the Bioanalytics Laboratory daily operations in relation to scheduling testing, project planning, management of materials, reagents, equipment, and laboratory staffReviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioanalytics Lab activitiesEnsures lab operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory ControlsRepresents the Bioanalytics Lab during Amgen internal/external audits and inspections.Direct interaction with regulatory agencies during on-site inspectionsProvides oversight of Bioanalytics Lab Quality Systems records including, lab investigations, Deviations, CAPAs and Change ControlsSelects, develops, and evaluates laboratory staff to ensure functional objectives are metHandles assignment and accuracy of staff trainingSupports Continual Improvement and LEAN initiatives, programs and projects.Ensures that changes that could potentially impact product quality are assessed according to procedures.Ensures that deviations from established procedures are investigated and documented per procedures.Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements.Collaborates cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.Alerts senior management of quality, compliance, supply and safety risks.Supports internal/external audits and inspections as part of the audit/inspection management team.,

Created: 2025-10-27