DESCRIPTION
Location/Division Specific Information: Greenville, NC
How will you make an impact?
This position works at the departmental level and is responsible for determining true root cause for select operational issues and implementing effective Corrective Action Preventative Actions (CAPAs).
The Root Cause Analyst (RCA) is responsible for leading, facilitating and providing subject matter expertise as well as supporting Greenville site personnel with identification robust root causes to prevent manufacturing deviations. Additionally, responsible for maintaining quality aspects of the RCA process, training and developing unique solutions that will help reduce reoccurring incidents. This role has a high level of visibility across the organization and provides feedback and solutions for risk reduction.
What will you do?
- As a crucial member of the Technical Unit (TU), identify root causes, and provide support in the implementation 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.
- Provide 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 documented investigations in an appropriate and timely manner.
- Support the implementation of CAPAs that reduce or eliminate recurrence of issues. Ensures the CAPA addresses true root cause.
- Work independently, as well as collaborate with TU to get results, meet timelines, and improve processes.
- Effectively communicate with peers, colleagues, and site leadership regarding status of root cause findings and recommendations.
- Provide technical experience and interpretation of data and results.
- Flexible schedule to meet the needs of the business.
- Other job duties as assigned.
REQUIREMENTS
How will you get here?
Education:
- BS/BA in biology, biochemistry, engineering, or other science related field preferred or an appropriate level of RCA leadership experience.
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 demonstrated 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.
Equivalency:
- Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities:
- Solid technical writing skills required.
- Solid communication skills.
- Knowledge of Microsoft Office Tools.
- Ability to drive functional, technical, and PPI.
- Ability to evaluate data and make recommendations based on data.
- Ability to make recommendations based on trends and trend analysis.
- Ability to work in a fast-paced environment with the ability to prioritize effectively to meet timelines.
- Facilitation skills for groups including staff level employees.
