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
DESCRIPTION:
Join our Quality Control team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff QC Engineer/Scientist, you'll lead quality initiatives and serve as a technical subject matter expert in analytical testing, method validation, and compliance. You'll 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, you'll work cross-functionally to lead method development, validation, and transfer activities while providing expert technical guidance on investigations and process improvements. You'll 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:
• Bachelor's 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.
