Quality Engineer Senior

Position Overview/Summary
As a Senior QualityAssurance Specialist (Technical Support) partner with manufacturing and support teams(e.g. MTS, IT/ Lean, Automation, Facilities) to:
(1) ensure indirect manufacturing activities such as major/ critical deviations, CAPA, tasks, change control, MDI and Lean events are progressed in a compliant and timely manner to meet site targets.
(2) function as the conduit between the Quality Systems team and the value stream to identify and implement meaningful corrective actions arising from agency inspections and internal audits.

Co-ordination-
Develop the technical (process) and quality systems expertise across the value stream.
- Engage with manufacturing specialists and designated support team members to ensure compliance and business targets are met for all compliance metrics.
Change Control -
Manage the change control process within the value stream
- Schedule and co-ordinate CCR review meeting
- Develop and report CCR metrics which drive results for the value stream
Deviations
Partner with manufacturing and technical support team members to resolve major and critical deviations within agreed timelines, and verify CAPA effectiveness.
- Partner with manufacturing and support teams to close of CAPA and tasks within allotted timelines
- Generate metrics at the required frequency which drive accountability and delivery of targets
Lean Initiatives/ Continuous Improvement - Engage with the Lean team to support continuous improvement of our quality and manufacturing systems using Lean tools and implementation of actions arising from Lean and other continuous improvement events
- Support Lean events constructively challenging the current state
Quality Systems -
Interface with the Quality Systems team members and the value stream to ensure effective identification and implementation of corrective actions coming from agency inspection and internal audits.
- Partner with the Quality Systems Organization to drive consistency across the value streamsLeadership QualificationsAbility to lead, manage and motivate cross-functional teams
- Build effective cross functional relationships
- Excellent interpersonal/ communication skills
- Execution mentality to drive tasks to closure
- Experience in problem solving and operating in a Lean culture


Basic QualificationsRequired:Bachelor's degree in Science/Engineering and 5-8 years directly relevant experience in biotechnology/pharmacuetical arena. Advanced degree preferred
- Experience in quality systems
- Demonstrated ability to lead and motivate teams in biological manufacturing technology
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