Scientist, Quality Control

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

Essential Functions:
- Perform chemical analysis of raw materials and pharmaceutical products (including stability samples) using written/compendial methods and material specifications; techniques include IR spectroscopy, UV-Vis spectroscopy, and chromatographic methods.
- Prepare samples for analysis with cleanliness and complex chromatographic steps; maintain laboratory records (notebooks and computer-based), document procedures, and calculate/report results timely.
- Participate in method transfer activities between facilities/organizations.
- Participate in and lead out-of-specification (OOS) laboratory result investigations, when required.
- Perform physical analysis using techniques such as X-ray diffraction, DSC, and Malvern mastersizer.
- Prepare and execute method transfer and method verification/validation protocols.

Additional Responsibilities:
- Assist senior scientists as needed.
- Remove expired chemicals/reference standards; perform calibrations of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, and GC as assigned.
- Standardize API for use as an in-house reference standard.
- Train laboratory technicians/Assistant Scientists on analytical techniques and instruments.

Qualifications:
- Education: BS/BA in Chemistry or related science (Required); Master’s in Chemistry or related science (Preferred).
- Experience: 3+ years testing chemicals/pharmaceutical products with BS/BA; 1+ year with Master’s.

Compensation: Base salary ranges from $75,000 to $103,000 per year.