QC Scientist III
Posted 1 month ago Expired
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Upload Your ResumeAbout This Role
As a QC Scientist III, you will perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. You will work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements.
Responsibilities
- Conduct complex analytical testing
- Lead method validations
- Perform data review
- Troubleshoot technical issues
- Execute and review tests for product release, stability, and in-process samples
- Author and review technical documentation
- Participate in investigations
- Interface with clients and regulatory authorities
Requirements
- Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control
- 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
Qualifications
- Advanced Degree or Bachelor's Degree in Chemistry, Biology, Biochemistry, or related scientific field
- Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control
Nice to Have
- Experience mentoring team members
Skills
* Required skills
About Thermo Fisher Scientific
Thermo Fisher Scientific is a company that enables customers to make the world healthier, cleaner and safer, providing solutions for some of the world's toughest challenges, across various industries including pharmaceutical, biotechnology, clinical labs, academia, government, environmental, and foo...