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Entry level$20B raised
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Skills: Root Cause Analysis, CAPA Implementation, 5-Whys, Fishbone/6M, TapRoot
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CACI
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Fayetteville, North Carolina, United States · On-site
$78k–$164k/yr
Mid level
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Wilkes County, North Carolina, United States · On-site
Mid level$9.0B raised
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Charlotte, North Carolina, United States · On-site
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Asheville, North Carolina, United States · On-site
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Charlotte, North Carolina, United States · On-site
Senior$40M raised
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Morrisville, North Carolina, United States · On-site
Mid level$1.5B raised
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Cumberland County, North Carolina, United States · On-site
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Full-time
bachelor degree
Posted 31d ago
~40 hrs/week
Responsibilities
The Root Cause Expert is responsible for identifying the true root cause of operational issues and implementing effective Corrective Action Preventative Actions (CAPAs). This role involves leading cross-functional teams to prevent manufacturing deviations and providing technical data interpretation to reduce recurring incidents.
Requirements
A bachelor's degree in biology, biochemistry, engineering, or a related science field is preferred, along with 1-2 years of experience using problem-solving tools. Candidates must have experience in a regulated environment, such as biologics or pharmaceuticals, and possess strong technical writing and communication skills.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
When you're part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.
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.
Related keywords
Root Cause AnalysisCAPAGMPBiologicsPharmaceuticalsLean Six SigmaPPI5-WhysFishboneTapRootKepnor-TregoeComparative AnalysisTechnical WritingManufacturing DeviationsQuality ControlPPE
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How much do Security & Safety jobs in North Carolina pay?
Based on 1012 listings with disclosed salaries, most security & safety jobs in North Carolina pay between $55k–$158k per year. Individual offers vary with seniority, company size, and specialization.
How many Security & Safety jobs are open in North Carolina right now?
There are currently 4,807 open security & safety positions in North Carolina listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Security & Safety roles in North Carolina?
Companies currently hiring include Allied Universal, North Carolina Department of Environmental Quality, The GEO Group, Inc., American Addiction Centers, Truist, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Security & Safety jobs in North Carolina?
Yes — 468 of the 4807 open security & safety positions offer remote or hybrid work (145 remote, 323 hybrid).
How do I apply for Security & Safety jobs in North Carolina?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.