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Deviation Management Specialist - II- Human Factor

Location: West Point, Pennsylvania 19486
Posted:Tue, February 09, 2021
Salary:Up to US$0.00 per year
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Requirements Education: BA or equivalent in relevant quality system or BS technical with operations and continuous improvement background achieved from professional experience. Strong planning and organization skills. Project management experience (execution not planning). Good communication skills and customer focus experience. Knowledge of deviation management systems including CAPA. Change management knowledge and demonstrated deployment. 5+ yrs. experience (deviation, quality, etc.). *Human performance deviation experience heavily preferred*. Human Factor SME, translating into leading, influencing and completion of assignments. Lead problem solving at critical issue level. Change manager - systems, capability. Strategic development for change programs. Operational Excellence, Lean programs. Communication -strategy and deployment. Production management. Quality systems - Deviation Mgt, RCA, CAPA. Create storytelling to demonstrate how we can learn as an organization from human factor analysis. Systems thinker to manage local and global priorities. Excellent writer and organized thinker. Manage discussion with tact and diplomacy. Searching out ways to continually improve. Researching new approaches and implementation. Desirable Experience 5+ yrs. pharma experience (if they have Human performance experience it's OK with no pharma). Experience of raising standards through continuous improvement. Exposure to GMS functions and experience of how to draw on the ability of experts. Working across functions and sites to achieve a common deviation reduction goal.

Specialist for human performance. Candidate will oversee the tactical reduction in Human Related Deviations for assigned areas in the Vaccine Operations at the West Point plant site. Meet directly with site operations teams to execute, influence, lead, and drive culture and mindset change. Following the BPOG Blue Sky description and model of Human Performance in biotech manufacturing operations, and in conjunction with a support team, execute tactical changes where application, focused on: personal execution of projects and effective education through doing/showing which changes mindsets and thinking; integrated change in HOW all aspects of manufacturing and manufacturing support are done; management and leadership behavior change. Candidate will implement human performance execution and culture change focused on proactive behavior and system improvement. Scope: integrating and building on existing change activities aligned to site targets: Quality systems include but are not limited to: Data Integrity, Deviation and CAPA, Performance Leadership, Human Factors supporting Quality Culture and Human performance 1. Do the actual work within the operational areas to reduce the occurrence and reoccurrence of Human Related Errors across the organization. 2. Develop the change strategy for assigned site areas in prioritized vaccine operations utilizing human factors, quality systems standards and change management. 3. Execute the direction and support deployment for the agreed strategy that enables improved resilience of assigned site areas to manage change, mitigate risks and achieve performance KPIs. 4. Build individual and team capability in areas identified by the Lead Human Performance Specialist for focus. 5. Identify and exploit opportunities to reveal the social nature of the high-performance workplace that puts the people and sites first, and shares best learnings 6. Develop a assigned site area model to reduce the opportunities for human error and consequent deviations 7. Develop behavioral Gemba and integrate into leadership standard work to provide insight into potential human error traps and opportunities to create conditions for success. 8. Develop training & education material for human performance if required and implement in partnership with Learning Manager and GL&D 9. Support Human factor and Deviation / RCA training to develop sustainable site practitioners 10. Support communications delivery and review feedback for improvement opportunities including meaningful KPIs. Provide expert leadership, execution, facilitation, and knowledge sharing on human factors elements for significant issues, deviations as directed by Director, MMD WP Site Learning and or Lead Human Performance Specialist.

Kindest Regards

Ruchi Kumari
Talent Acquisition Specialist
Experis CORE
100 Manpower Place | Milwaukee, WI 53212
Desk # - 414-203-8334, Ext-7140

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