QC Scientist III
Share
Job Location:
Saint Louis, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
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
How will you make an impact
Join our collaborative team at Thermo Fisher Scientific where youll contribute to our mission of making the world healthier cleaner and safer. As a QC Scientist III youll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. Youll work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements. This role offers significant opportunities to grow your expertise while supporting the development and manufacturing of life-changing therapeutics.
Youll conduct complex analytical testing lead method validations perform data review and troubleshoot technical issues. Key responsibilities include executing and reviewing tests for product release stability and in-process samples; authoring and reviewing technical documentation; participating in investigations; and interfacing with clients and regulatory authorities. Your work will directly impact patient safety and product quality while advancing scientific innovation.
A Day in the Life:
- Conduct GMP testing in an analytical laboratory environment using Separation Techniques BioAssay Analysis and Compendia test methods ( Phase SEC Titer concentration iCE pH Osmolarity Residual DNA Appearance)
- Help develop and build the foundation of a liquid chromatography technical team by implementing standard practices and policies.
- Perform testing on In-Process DS release DS stability DP Stability and various other non-routine samples ensuring timely delivery for projects
- Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions
- Participate in analytical method validation/transfer method establishment/qualification routine and stability analysis.
- Compiles data for documentation of test procedures prepares reports. Ensures all testing processes monitoring and departmental documentation meet SOPs and cGMP regulatory standards.
- Participate in the development of new concepts techniques and standards. Involved with assisting in the preparation of CoAs.
- Perform all duties in compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines
- Participating in laboratory activities including safety inspections and client audits
- Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists quality control quality assurance process engineers and our customers.
Keys to Success:
Advanced Degree plus 3 years of experience or Bachelors Degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control
Preferred Fields of Study: Chemistry Biology Biochemistry or related scientific field
Expertise in analytical techniques such as HPLC UPLC CE-SDS cIEF/ICE ELISA and cell-based assays
Strong knowledge of FDA EMA ICH and GxP regulations
Experience with method validation transfer and qualification
Proficiency in data analysis and laboratory information management systems
Advanced technical writing and documentation skills
Strong project management and organizational abilities
Excellent interpersonal and communication skills
Ability to work independently and lead cross-functional teams
Experience with quality investigations and CAPAs
Proficiency with Microsoft Office Suite and relevant analytical software
Ability to wear PPE and work in laboratory environments
May require weekend/flexible scheduling based on business needs
Physical requirements include standing lifting up to 25 lbs and manual dexterity
Strong attention to detail and problem-solving skills
Experience mentoring team members preferred
Excellent Benefits
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
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:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
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
