Chemist I

Avet Pharmaceutical•East Brunswick Township, NJ

3d•$0 - $30•Onsite

About The Position

Avet Provides high-quality generic medicines and is built around centers of manufacturing and scientific excellence to provide you with the highest level of quality, safety, value, and service in generics. The Chemist I – role responsible for performing testing of Raw Material, Excipients, and packaging component. Knowledge and understanding of USP, EP, BP monograph. Work experience of 2-3 years. Knowledge of FTIR, DSC, Malvern particle size analyzer, Potentiometric titration, UV. Clearly, concurrent document activities performed during testing and to calculate and report results on applicable specification documents. Follow cGMP regulations. Understand the US Guidelines and monographs. Chemists must maintain organization and meet compliance under USP regulations while working in a fast-paced environment to meet priority deadlines.

Requirements

Minimum BS in Chemistry or science related field with 0-5 years of experience in science regulated discipline.
Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: Primarily High Performance Liquid Chromatography (HPLC), UV/Vis spectrophotometer, TLC, pH meters, analytical balances including but not limited to moistures, hardness, and friability.
Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result.
Computer skills for operation of laboratory equipment and for data processing/storage.
Has the ability to understand and follow written methodologies in accordance with CGMP standards.
Understands and applies USP general chapters.
Ability to work on laboratory investigations initiations like Event, LDN, OOT and RMF.
Minimum English proficiency requirements.
Legally authorized to work in the U.S. for any employer.

Nice To Haves

Wet chemistry, dissolution, HPLC/GC Chromatography functional knowledge is preferred.
Knowledge and understanding of USP, EP, BP monograph.
Knowledge of FTIR, DSC, Malvern particle size analyzer, Potentiometric titration, UV.
Work experience of 2-3 years.

Responsibilities

Performs routine raw material testing under cGMP guidelines in a team environment.
Maintains laboratory documentation with details of test procedures, raw data, and final results in accordance with regulatory guidelines.
Performs calibrations, standardizations, and routine maintenance of instrumentation as needed.
Performs initial investigative work related to out-of-specification lab results with input from senior chemists and supervisors. Conducts formal investigative procedures and aids other chemists in resolving method and instrument problems.
Manages routine testing support for QC samples (Dissolution/HPLC/GC/Physical testing), Conducts laboratory disposition of materials (waste/expired chemicals) under cGMP guidelines.
Ensuring that laboratory documentation complies with regulatory guidelines. Responds to out-of-specification test results in accordance with regulatory guidelines and quickly isolates material issues from testing issues.
Organizes workflow within the team framework to ensure high throughput and quick response to production priorities.
All other job-related duties.