QC Scientist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world including giving patients hope.

EDUCATION

• Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.

EXPERIENCE

• At least 3 years working in a regulated laboratory environment. GMP experience preferred.
• At least 2 years of HPLC experience performing assay/related substance analysis and other chromatographic techniques. Experience with Empower software is preferred.
• Experience with dissolution and other analytical techniques is preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS, ABILITIES

• Hands-on experience with various analytical techniques, including: HPLC, GC, Dissolution
• Ability to work independently and in a team setting.
• Strong knowledge of Good Manufacturing Practices and data integrity (ALCOA).
• Good critical and logical thinking skills.
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Typically requires standing and walking for a shift.
• Occasionally requires lifting of up to 20 pounds.
  Requires manual dexterity and visual abilities.

• Work in a fast-paced GMP environment performing testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
• Record and report results of analysis in accordance with lab procedures, GDP, and ALCOA.
• Review and interpret analytical test results. Make recommendations based on data.
• Recognize and report deviations, out-of-specifications OOS, or unexpected results and recommend solutions.
• Maintain a clean and organized laboratory workspace consistent with management expectations.
• Clean, calibrate, and troubleshoot analytical instrumentation as needed.
• Author Standard Operating Procedures (SOPs), deviation reports, and other documents as needed.
• Collaborate with various functional areas to meet project and team objectives.
• Manage projects at a broad task level under minimal supervision, ensure deliverables are met and identify next steps.
• Train other scientists.
• Perform all duties in strict compliance with SOPs, GMPs, GLPs, and safety guidelines.