2 qa specialist jobs found

This role supports and maintains compliance of QA Operational Team, inclusive of but not limited to QA Operations; Document Control; QA Raw Materials and QA Systems with mandated regulatory requirements and site expectations. As a QA Specialist/ Sr QA Specialist a typical day might include, but is not limited to, the following:   Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP). Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance. Reviewing and approving of the following types of documents: Failure investigations associated with deviations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP’s), GxP documents & Change control documents. Supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver. Reviewing procedures, policies and other...

Within this role you will support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of sourcing management. You'll ensure organization and timely completion of Approved Supplier List documentation in addition to process deviations assigned to sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers. This is a 12-month temporary contract position. As a Compliance Specialist, a typical day might include, but is not limited to, the following:   Supporting and proactively maintaining all procurement cGMP procedures, documentation and training related to SOP and Work Instructions Maintaining and managing the Approved Supplier List (ASL) Addressing compliance needs and coordinating with other sites to ensure engagement, feedback and buy in related to procurement document revisions Driving successful...