Root Cause Analyst

Location

Greenville, NC | United States

Job description

Root Cause Analyst

When your 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.

COMPANY INFORMATION:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues 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 and Patheon. For more information, please visit

GROUP/DIVISION SUMMARY:

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 44 00 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

Location/Division Specific Information:

Greenville, NC

Position Summary:

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. The Root Cause Analyst uses a combination of project management, facilitation, leadership, and continuous improvement skills to facilitate Root Cause Analysis, development of standards, best practices, and performance improvements. This role has a high level of visibility across the organization and provides feedback and solutions for risk reduction.

Key Responsibilities:

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.
Demonstrates and drives the Thermo Fisher values Integrity, Intensity, Involvement, and Innovation (The Four Is).
Demonstrates and promotes the company vision (Zero Deviations).
Other job duties as assigned.

Education:

BS/ BA in Engineering, Sciences, Business, or 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:

Good problem solving and excellent team working attitude.
Knowledge of cGMP
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.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

BENEFITS:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us ( As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

APPLY TODAY!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

ACCESSIBILITY/DISABILITY ACCESS:

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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