Associate Scientist, Quality Control
Amneal
Summary
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, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.
Job description
Essential Functions
- 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.
Additional Responsibilities
- 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.
Qualifications
Education: Bachelors Degree (BA/BS) Chemistry or related field - Required
Experience: less than one year in Testing of chemicals/pharmaceutical products; 1 year or more in Testing of chemicals/pharmaceutical products
Specialized Knowledge: 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.
Requirements
- Bachelors Degree (BA/BS) in Chemistry or related field
- Working knowledge of analytical chemistry techniques
- Experience testing chemicals or pharmaceutical products
- Ability to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests
- Understanding and application of cGMP requirements applicable to quality control laboratory
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.