Overview

Chemist II Jobs in Lexington, Kentucky, USA at Piramal Pharma Ltd

Business:
Pharma Solution
Department:
Quality Control

Location:

Lexington

Job Overview

The primary purpose of the role is to perform complex testing of raw materials, in-process and finished products, maintain and calibrate analytical instruments in compliance with cGMP standards. This is a night shift role.

Reporting Structure

Directly reports to AQC Group Lead

Key responsibilities

Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc. with minimum supervision.

Testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.

Proficient at HPLC/GC analysis

Document laboratory work according to GDP, cGMPs, and SOPs

Troubleshoot, calibrate and maintain instruments as required.

Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.

Write SOP’s, laboratory protocols and reports, memos and/or other interdepartmental correspondence

Initiate and resolve laboratory investigations.

Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.

Perform peer review of analytical documentation.

Follow safety procedures when working in laboratory.

Understand and comply with cGMPs and other regulations.

Maintain the laboratory in an organized and neat manner.

Purchasing of laboratory reagents and consumables.

Education

Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field

Experience

Minimum 3+ year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis

Previous experience working within cGMP guidelines

Experience working with potent, cytotoxic materials and parenteral drug products preferred

Competencies

High level of proficiency operating all Microsoft Office applications

Excellent communication skills, both verbally and in writing

Detail oriented and organized

Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility

Excellent problem solving, communication, and interpersonal skills

Ability to follow written instructions

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Title: Chemist II

Company: Piramal Pharma Ltd

Location: Lexington, Kentucky, USA

Category: Healthcare (Data Scientist, Medical Science), Quality Assurance – QA/QC

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