Job Information
BioFire Diagnostics, LLC. Associate Manager, Quality Release in Hazelwood, Missouri
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:
Bachelor’s degree and 3 years relevant GMP experience OR
Associate’s degree and 5 years relevant GMP experience
High School Diploma or GED and 7 years relevant GMP experience
3+ years of team organization or leadership experience
Experience working in a GMP / FDA regulated production environment
Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.
Experience in leading teams and individuals: organizing training of peers and management, organizing team activities and tasks, attending cross departmental meetings for quality investigations, creating PMP goals and aligning with team.
Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
Strong interpersonal skills and ability to work with all levels of an organization.
PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
Prior knowledge of MES, SPC, or SAP a plus
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