Job Description

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

When you’re part of the team at ThermoFisher Scientific, you’ll 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’ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO/Biologics Division

How will you make an impact?

The QC MICRO Investigation writer II will operate in a high-throughput environment,

completing investigations on behalf of the QC Micro and EM groups.

This person is responsible for leading multiple investigations simultaneously and ensuring

on-time completion through dedication, tenacity and relationship building with

our partners in QA and the various testing groups. As a strong individual contributor,

the QC MICRO Investigation writer II will maintain a steady record closure rate

while working on moderate complexity investigations, with some variance in difficulty based on

the availability. They will also assist more junior investigators when

needed and will participate in QC compliance activities related to audits and

continuous improvement.

What will you do?

• Stay current with training in Success Factors and Thermo Fisher University

• Occasionally conduct RAPID meetings with QA and QC staff

• Use TrackWise software to author investigations

• Be responsible for compliance-related deliverables including: audit

support/observation response, presentations to senior management and

site leadership, and generating trend reports to better understand the

weaknesses in our organization and make suggestions for improvement

• Support compliance culture initiatives and assist manager and supervisor

with implementing these changes.

• Develop the team through creation/delivery of proactive and reactive

trainings.

• Assist with the development of tools and resources to improve our

investigative process.

• Assist Scientist I investigators when needed

• Average 3-4 deviation/OOS/CAPA record closures per month, based on

complexity

• Complete overdue assessments and file record extensions as required

• Author/revise SOPs (limited)

• Assist with formulating continuous improvement strategies and timelines

• Other job duties as assigned

How will you get here?

• Bachelor’s degree in science related field is a plus but not required. HIgh School Diploma required.

• 3 or more years working in a GMP regulated environment or Quality Role

(QA or QC) preferred.

• 2 or more years as an investigation, CAPA, and deviation writer preferred.

• TrackWise and TapRooT experience is preferred.

Knowledge, Skills, Abilities

• Knowledge of GMP regulations

• Knowledge of Good Laboratory Practices (GLP) and Good Documentation

Practices (GDP)

• Able to read, write, and communicate in English.

• Able to use standard computer programs such as SmartSheet, PowerBI, MS

Excel, Word, and PowerPoint.

• Able to inspire innovation and team effectiveness.

• Able to work in an evolving environment and adapt to a variety of internal

customer’s needs

• Strong computer, scientific, and organizational skills.

• Strong communication skills including active listening, facilitation, and

escalation

• Enjoys collaborative efforts both internal and external to the department

Physical Requirements / Work Environment:

Wear gloves and other PPE to enter laboratory spaces

Sit for extended periods of time. This role requires a lot of desk time and meeting

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!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

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