Senior Scientist, Quality Control

Role Summary

The Scientist 3 - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples following written procedures and applicable SOPs. The role involves calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations, and providing feedback on systems and analytical procedures to promote continuous improvement and enhanced compliance posture.

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; comply with cGMP, SOPs, and STPs to avoid out-of-specification situations and ensure regulatory compliance.
• Actively participate in project work; perform process validation and cleaning validation/verification testing; assist other scientists with analytical, instrument, and software-related problems as required.
• Operate 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 and/or in-line UV, pH meters, analytical balances, and 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 and adherence to company policies.
• 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:
  • Bachelor’s Degree (BA/BS) in Chemistry or related science discipline – Required
  • Master’s Degree (MS/MA) in Chemistry or related science discipline – Preferred
• Experience:
  • With a Bachelor’s Degree – 5+ years of testing chemicals/pharmaceutical products
  • With a Master’s Degree – 3+ years of testing chemicals/pharmaceutical products
• Skills:
  • Must be 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 and issues, both verbally and in writing.
  • Ability to take on a leadership role when required.
  • Proficiency with MS Office and LIMS-related software.
  • Willingness to work extended hours, including weekends, as required.
  • Adherence to safe practices per MSDS and compliance with state/federal regulations.
  • Ability to maintain clear laboratory records and communicate across departments.
  • Solid understanding of cGMP in pharmaceutical QC and method verification/validation concepts.
  • Ability to review laboratory records for compliance with specifications, methods, and SOPs.
• Specialized Knowledge:
  • In-depth knowledge of analytical chemistry techniques (spectrophotometric, dissolution and drug release, chromatographic techniques, and physical parameter measurements).
  • Ability to follow compendial (USP/EP/BP/JP) procedures for analysis.
  • Understanding and application of cGMP requirements in quality control laboratories.
  • Ability to troubleshoot complex analytical and instrument-related problems and report actions to management in a timely manner.
  • Ability to identify trends in analytical data.

Education

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