Scientist, Quality Control

About the role

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, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

Responsibilities

• Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes.
• Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Participates in method transfer activities between facilities within the organization or between organizations.
• Participates in and leads investigation of out-of-specification laboratory results, when required.
• Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern Mastersizer.
• Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Qualifications

• Education: Bachelor's Degree (BA/BS) Chemistry or related science discipline - Required
• Experience: With Bachelor's Degree (BA/BS) - Testing of chemicals/pharmaceutical products, 3 years or more
• Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Pay

The base salary for this position ranges from $75,000 to $103,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.

Schedule

Not specified