Associate Manager, Quality Release

Description

Position Summary:

The Associate Manager of Quality Release is responsible for having lot related oversight for batch record completion - this includes MES and paper documentation exception review, in process approval forms, segregation approvals, rework approvals, and participation in review boards.

Individual may also be supporting real time quality oversight relating to deviations and investigations, as applicable, and will be responsible for releasing specialized lots related to deviations and investigations and may also support QA GEMBA for process and improvement opportunities. The will be the primary coordinator of lot status, release needs, collaboration between Supply Chain, Production, and Quality Control. This QA role may be required to support continuous improvement activities and will coordinate and prioritize lot releases with the Quality Specialists

Primary Responsibilities:

• Review and approve In-Process MES exceptions, lot segregations, containment of rejected materials, and support changeover inquiries.

• Upon collation of lot documentation from production and QC - perform SAP lot release

• Support manufacturing and QC in the initiation of Trackwise deviations in real time, as applicable

• Supports nonconformance investigations and product inspections using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.), as applicable.

• Authors and reviews GMP documents including procedure revisions and specified reports, to support continuous improvement and the change control process.

• Implements and completes continuous improvement projects as required.

• Supports internal/external audits.

• Lead and coordinate Quality Release team activities and support group metrics for monthly release targets.

• Support PMP efforts for team and monitor team performance.

Education, Skills, & Experience: