Quality Scientist

Merck•Miamisburg, OH

4d•Onsite

About The Position

The Quality Scientist evaluates stable isotope products according to established protocols and develops, improves, and optimizes analytical methods to ensure process and product quality. This role is responsible for commissioning and qualifying new analytical instrumentation, leading out-of-specification (OOS) investigations, and training/mentoring other scientists.

Requirements

Bachelor’s degree in chemistry or a similar Life Science discipline AND 9+ years of QC laboratory experience.
OR Master’s degree in chemistry or a similar Life Science discipline AND 5+ years of QC laboratory experience.
Must be able to operate laboratory and office equipment, view computer monitors for extended periods and occasionally move or transport laboratory materials weighing up to 50 pounds.
Requires the ability to work near moving mechanical parts and occasionally outdoors during material transport.
Must be able to wear required Personal Protective Equipment (PPE) including safety glasses/goggles, chemical-resistant suits, gloves, and safety shoes when handling toxic, corrosive, or airborne chemicals.

Nice To Haves

Extensive experience with multiple core chemical analysis techniques (e.g., GC, HPLC, IR, UV, NMR, MS) and spectral data interpretation/structural elucidation.
Proven experience authoring experimental procedures, validation protocols/reports, and investigation reports.
Strong hands-on skills with chemical glassware, heating mantles, vacuum lines, and troubleshooting chemical reactions.
Proficient in basic lab calculations (pH, molarity, stoichiometry).
Strong organizational, time-management, and oral/written communication skills.
Proficiency with Excel math functions is a plus.

Responsibilities

Perform highly skilled, multi-disciplined assays on stable isotope compounds.
Lead technical investigations for OOS results, deviations, and process improvements under change control.
Complete data integrity audits, audit trail reviews, and validation activities in accordance with corporate procedures and 21 CFR Part 11.
Generate, validate, and conduct technical/final reviews of analytical methods, validation reports, and technical documents.
Commission and qualify new analytical instrumentation.
Identify and implement process improvements to increase testing precision, accuracy, and throughput.
Train and mentor personnel, acting as a technical consultant.
Interface with internal departments, external customers, and participate in quality audits.
Serve on site-improvement committees (safety, quality, cost, etc.).