QC Scientist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Location/Division Specific Information

The Bend, Oregon Thermo Fisher Scientific site consists of approximately 90 highly motivated employees focused on contract early phase clinical drug product development and manufacture. Bend, Oregon is a community of around 105,000 people commonly known as 'the outdoor playground of the West' because of the myriad of available outdoor activities and desirable living conditions.

How will you make an impact?

A Quality Control (QC) Scientist III will perform release and stability testing of raw materials, in-process, and finished product for clinical research and development materials. Personnel will act as an SME in various areas and manage multiple technical/scientific processes.

What will you do?

• Perform complex testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, DSC, and KF.

• Record and report results of analysis in accordance with lab procedures, GDP, and ALCOA.

• Review and interpret complex analytical test results. Make recommendations based on data.

• Recognize and report deviations, out-of-specifications OOS, or unexpected results and develop testing plans.

• Perform method development or validation.

• Maintain a clean and organized laboratory workspace consistent with management expectations.

• Clean, calibrate, and troubleshoot analytical instrumentation as needed.

• Lead technical discussions while collaborating with various functional areas to meet project and team objectives.

• Manage multiple project timelines ensuring deliverables are met.

• Interact with customers and auditors.

• Lead multiple initiatives to improve laboratory operations and complete assignments.

• Train and mentor other scientists.

• Author Standard Operating Procedures (SOPs), deviation reports, training materials, and other documents as needed.

• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the vital compliance status required by company and facility standards.

Education and Experience

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

• At least 7 years working in a regulated laboratory environment. GMP experience preferred.

• At least 3 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

• Excellent analytical testing skill including: HPLC, GC, Dissolution

• Ability to work independently and in a team setting.

• Excellent knowledge of Good Manufacturing Practices, FDA regulations, ICH Guidance, and data integrity (ALCOA).

• Excellent attention to detail and ability to prioritize

• 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.