Thermo Fisher Scientific · 1 day ago
QC Scientist II - QC Analytical
Thermo Fisher Scientific is a leading organization dedicated to enabling customers to make the world healthier, cleaner, and safer. The QC Scientist II role focuses on conducting complex analytical testing to support GMP manufacturing of biopharmaceutical products, ensuring product quality and safety through precise quality control testing.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Perform complex analytical testing in support of GMP manufacturing, including in-process, release, and stability testing
Execute validated test methods and support method development, validation, and transfer activities
Operate and troubleshoot analytical instrumentation such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical platforms
Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, including root cause analysis and technical report authorship
Maintain accurate, thorough, and compliant documentation in accordance with cGMP and data integrity requirements
Utilize Laboratory Information Management Systems (LIMS) and quality management systems to document and review data
Support health authority and internal audits, inspections, and regulatory commitments
Collaborate with manufacturing, quality assurance, and development teams to resolve issues and improve analytical processes
Participate in continuous improvement initiatives to enhance laboratory efficiency, compliance, and robustness
Follow all safety, aseptic technique, and environmental monitoring requirements
Qualification
Required
Advanced degree (MS or PhD) in Chemistry, Biology, Biochemistry, or a related scientific field with no prior experience, or
Bachelor's degree in a scientific discipline with 2+ years of experience in a GMP-regulated laboratory environment performing analytical testing
Hands-on experience with analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods
Experience working in a cGMP-regulated environment
Demonstrated experience investigating OOS results and authoring technical documentation
Strong understanding of cGMP regulations, quality control principles, and data integrity requirements
Knowledge of aseptic techniques and environmental monitoring procedures
Proficiency with Microsoft Office applications
Experience with LIMS and electronic quality management systems
Strong problem-solving, analytical, and organizational skills
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a fast-paced laboratory environment
Ability to manage multiple priorities while maintaining attention to detail
Willingness to work flexible schedules, including occasional weekend work
Ability to lift up to 30 pounds
Ability to stand for extended periods
Willingness to wear required PPE, including lab coat, safety glasses, and gloves
Preferred
Experience with method validation and method transfer activities
Familiarity with health authority audits and regulatory inspections
Benefits
Medical, Dental, and Vision coverage
Paid Time Off and designated paid holidays
Retirement Savings Plan
Tuition Reimbursement
Career development and growth opportunities
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Recent News
Business Standard India
2026-01-14
2026-01-14
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