Associate Scientist, Quality Control

Amneal

20h • Onsite

About The Position

The Scientist I - QC is an entry-level role responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples. This role requires following written procedures and applicable SOPs, clearly documenting activities performed during testing, and calculating and reporting results on applicable specification documents. Additionally, the position involves assisting other scientists, informing the QC Coordinator about expired chemicals or reference standards, performing calibration of various laboratory equipment, and preparing volumetric test solutions and standardizing APIs for in-house reference standards.

Requirements

• Bachelors Degree (BA/BS) in Chemistry or related field.
• Experience in Testing of chemicals/pharmaceutical products (less than one year or 1 year or more).
• Must possess a working knowledge of analytical chemistry techniques, such as analytical weighing, quantitative transfer, preparation of quantitative solutions, analytical dilutions, spectrophotometric analytical techniques, dissolution and drug release, disintegration, moisture determination (Karl Fischer, Coulometric, LOD), thin-layer chromatographic technique, gas chromatographic techniques, HPLC, and measuring physical parameters (bulk and tapped densities, and particle size by sieve analysis).
• Must be able to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

• Performs physical and 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 other analytical techniques as applicable.
• 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.
• Actively participates in investigation of laboratory results, when required.
• Assists, as and when needed, scientists working in the laboratory.
• Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
• Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.
• Prepares volumetric test solutions following USP or in-house methods for wet chemical tests, standardizes such solutions as required, standardizes API for use as in-house reference standard as assigned.

Benefits

• Comprehensive, flexible and competitive benefits program for eligible positions.
• Above-market, diverse and robust health and insurance benefits.
• Significant 401(k) matching contribution.
• Programs that help you enjoy your career alongside life’s many other commitments.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees