Work Schedule
Third Shift (Nights)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Fluctuating Temps hot/cold, Office

Job Description

How you will make an impact!

Perform Root Cause Analysis using the PPI Business System and other process improvement methodology, to drive root causes and create sustainable CAPAs. Use DIGITAL SME, maintenance effectiveness/reliability engineering data and Global TrackWise. Typical hours will be Monday - Friday, 12a - 9a. This is a salaried role.

• As a member of the Technical Unit (TU), identify root causes, and provide support of appropriate countermeasures. Work closely with operations and support teams.
• Be able to apply the fundamentals of Root Cause Analysis to include 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe and Comparative Analysis.
• Act as primary root cause support for major investigations including items originating from Production, Quality Control, Facilities, etc.
• Facilitate cross functional teams to evaluate causal factors.
• Provide written detailed investigations in an appropriate and timely manner.
• Identify and support the implementation of CAPAs that reduce or eliminate recurrence of issues during the deviation process. Ensures the CAPA addresses true root cause. Monitor CAPA efficiency post implementation.
• Work independently, as well as collaborate with colleagues, TU and site leadership to get results, meet timelines, and improve processes, to include status of root cause findings and recommendations.
• Provide technical experience and interpretation of data and results in response to customer RFIs, internal collaborators, and audit support.
• Lead Rapid events when present and able.
• Support document review and approval for all Ops related functions as assigned. Primary FAM approver for Ops.
• Responsible for Ops related deviation closure important metric achievement. Drive improvement and reduce Ops impacted deviation closure timeframe.
• Flexible schedule to meet the needs of the business.
• Other job duties as assigned.

• BS/ BA in biology, biochemistry, engineering, or other science related field preferred or an appropriate level of RCA leadership experience.

• 1-2 years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis, etc.) with shown success.
• Experience working in a regulated environment, preferably in biologics/pharmaceuticals.
• Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or PPI tools

• Equivalent combinations of education, training, and meaningful work experience may be considered.

• Technical writing skills required.
• Knowledge of Microsoft Office Tools
• Ability to drive functional, technical, and PPI.
• Ability to evaluate data and trends and make recommendations based on data.
• Ability to work in a fast-paced environment with the ability to prioritize to meet timelines.
• Solid Communications and Facilitation skills for groups including staff level employees.