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 applicable SOPs. Responsible for calculating and reporting results, participating in method transfer activities, and providing feedback to promote continuous improvement and compliance in analytical procedures.

Responsibilities

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specifications, and SOPs. Ensure compliance with cGMPs, SOPs, and STPs and with state and federal regulations.
• Participate in project work as assigned. Conduct process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument, and software-related problems as required.
• Operate and calibrate analytical instruments (sonic sifter, laser diffraction, Karl Fischer, UV-Vis, IR, HPLC with UV detection and conductivity detection, TLC, pH meter, dissolution; calibrate HPLC, dissolution apparatus with auto-sampler/inline UV, pH meters, analytical balances, Karl-Fischer titrator).
• Document steps followed during analysis, calculate and report results, and participate in investigations of laboratory results.
• Review laboratory analysis data for completeness and specification compliance, ensuring alignment with company policies.
• Report abnormal findings to the Supervisor and perform in-depth review of analytical records/reports to ensure calculations and data are correct and compliant with specifications.

Qualifications

• Bachelors Degree (BA/BS) in Chemistry or related science - Required
• Master Degree (MS/MA) in Chemistry or related science - Preferred
• With a Bachelors Degree: 5+ years of experience in testing chemicals/pharmaceutical products
• With a Masters Degree: 3+ years of experience in testing chemicals/pharmaceutical products

Skills

• Precise and consistent in day-to-day analysis; able to be trained and learn quickly.
• Strong teamwork orientation; adaptable to changing assignments.
• Ability to execute compendial procedures with minimal supervision.
• Effective written and verbal communication of results and issues.
• Ability to assume a leadership role in a team when required.
• Computer literate with MS Office and LIMS software.
• Willing to work extended hours, including weekends, as required.
• Adheres to safe practices per MSDS and applicable regulations.
• Maintains clear, concise laboratory records and communicates across departments.
• Familiar with cGMP in pharmaceutical laboratories and with 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

Experience

• 5+ years of testing chemicals/pharmaceutical products with a BA/BS
• 3+ years of testing chemicals/pharmaceutical products with an MS/MA