Senior Scientist, Quality Control

Role Summary

The Senior Scientist, Quality Control performs testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples following written procedures and SOPs. The role calculates and reports results, participates in method transfer activities, and provides feedback to promote continuous improvement and compliance.

Responsibilities

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods and specifications; comply with cGMPs, SOPs, and STPs to avoid out-of-specification results; ensure compliance with state and federal regulations.
• Participate in project work; perform process validation and cleaning validation/verification testing; assist other scientists with analytical, instrument, and software issues as required.
• Operate analytical instrumentation (e.g., HPLC, UV-Vis, IR, TLC, pH meters, dissolution, Karl Fischer, laser diffraction, spectrophotometers) and calibrate equipment (HPLC, dissolution apparatus, pH meters, analytical balances, Karl-Fischer titrator).
• Document steps followed during analysis, calculate and report results; participate in investigations of laboratory results; review data for completeness and specification compliance.
• Report abnormal findings to the Supervisor; perform in-depth review of analytical records to ensure calculations and data are correct and compliant with specifications.

Qualifications

Education

• Bachelors Degree (BA/BS) in Chemistry or related science discipline — Required
• Master Degree (MS/MA) in Chemistry or related science discipline — Preferred

Experience

• With a Bachelors Degree — 5+ years of testing chemicals/pharmaceutical products
• With a Masters Degree — 3+ years of testing chemicals/pharmaceutical products

Skills

• Precise and consistent in day-to-day analysis; easily trainable and eager to learn.
• Ability to work in a team and adapt to changing assignments.
• Ability to execute compendial procedures with minimal supervision.
• Effective communication of results, problems, or issues in writing and verbally.
• Ability to take a leadership role in a team when required.
• Computer literate with MS Office and LIMS software.
• Willingness to work extended hours, including weekends, as required.
• Adherence to safe practices per MSDS and compliance with state and federal regulations.
• Ability to maintain clear laboratory records and communicate across departments.
• Strong understanding of cGMP in pharmaceutical QC and method verification/validation concepts.
• Ability to review laboratory records for compliance with specifications, methods, and SOPs.

Education

• Bachelors Degree (BA/BS) in Chemistry or related science — Required
• Master Degree (MS/MA) in Chemistry or related science — Preferred