QC Staff Scientist
Job Location:
Saint Louis, MI - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our Quality Control team at Thermo Fisher Scientific where youll contribute to global healthcare and scientific advancement. As a Staff QC Engineer/Scientist youll lead quality initiatives and serve as a technical subject matter expert in analytical testing method validation and compliance. Youll support continuous improvement while ensuring the highest quality standards for our products that help customers make the world healthier cleaner and safer.
In this role youll work cross-functionally to lead method development validation and transfer activities while providing expert technical guidance on investigations and process improvements. Youll support team members communicate with clients and represent QC in regulatory audits. Your expertise will be essential in maintaining compliance with cGMP requirements and advancing our quality systems through innovative solutions.
REQUIREMENTS:
Bachelors Degree plus 10 years of experience preferably QC/analytical experience in pharmaceutical/biopharmaceutical industry
Extensive expertise in analytical techniques including HPLC ELISA cell-based assays and protein characterization methods
Strong understanding of cGMP FDA regulations ICH guidelines and quality systems
Proven experience leading method validation transfer and stability programs
Advanced technical troubleshooting and investigation skills for complex quality issues
Experience with quality documentation including SOPs validation protocols and regulatory submissions
Strong project management abilities to drive multiple concurrent initiatives
Excellence in data analysis and statistical evaluation using tools like Minitab/JMP
Proficiency with laboratory information management systems and quality tracking systems
Strong technical writing and presentation skills
Effective interpersonal skills with ability to guide and support others
Experience supporting regulatory and client audits
Demonstrated expertise in risk assessment and CAPA implementation
Proficient in Microsoft Office applications including Excel PowerPoint and Word
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.
Required Experience:
Staff IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
