Job Description
This is an 11-month contract and is a hybrid position. Purpose This is a contract-based role for an Associate Quality Control Specialist as part of the Incoming Quality team reporting to the Quality Control Manager. You will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required. Responsibilities Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification Participate and support Internal/External Investigations Coordinate the creation/ update to Quality standards for raw materials and components. Complete impact assessments for change controls related to processes Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility Coordination, ownership, and author as required for Annual Product Review Participate in Quality Risk Management Requirements Bachelors degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience 2-4 years of experience in a cGMP laboratory environments Knowledge of or previous experience in New Material Introduction process Proficiency in Microsoft Office and job related computer applications required Good communication, interpersonal skills and ability to work across teams Demonstrated ability to drive the completion of tasks Demonstrated ability to solve problems/perform investigations Method validation and method transfer experience would be advantage Skills: New Material Introduction cGMP Method Transfer Expereince