QC Investigations - Scientist II
QC Investigations - Scientist II
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
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
Job Title: Quality Engineer/Scientist II
Requisition ID:
When youre part of the team at ThermoFisher Scientific youll 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 realworld impact and youll be supported in achieving your career goals.
Location/Division Specific Information
St. Louis MO/Biologics Division
How will you make an impact
The Quality Engineer/Scientist II will operate in a highthroughput environment completing investigations on behalf of the various QC testing groups but primarily for QC Analytical. This person is responsible for leading multiple investigations simultaneously and ensuring ontime completion through dedication tenacity and relationship building with our partners in QA and the various testing groups. As a strong individual contributor the Quality Engineer/Scientist III will maintain a steady record closure rate while working on moderate complexity investigations with some variance in difficulty based on what becomes available. 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
Occasionally conduct RAPID meetings with QA and QC staff
Use TrackWise software to author investigations
Be responsible for compliancerelated 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 1 deviation/OOS/CAPA record closures per week
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
Bachelors degree in science related field required
3 or more years working in a GMP regulated environment or Quality Role (QA or QC)
2 or more years as an investigation writer CAPA developer or auditor.
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 customers 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 forwardthinking 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 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research resolve difficult 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!
Disclaimer:
This job description presents the general content and requirements for the performance of this job. The description is not to be construed as an extensive statement of work responsibilities or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to describe an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race color sex religion sexual orientation national origin disability genetic information pregnancy or any other protected characteristic as outlined by federal state or local laws.
Employment Type
Full-Time
