Chemist I

Business: Pharma Solution
Department: Analytical Quality Control (AQC)
Location: Lexington

Job Overview

The Chemist I performs testing of raw materials, in-process and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards.

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.

•    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

•    Participate in laboratory investigations

•    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

•    Act as backup for Material sampling activities.

•    Purchasing of laboratory reagents and consumables

Education Requirements

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

Experience

•    Minimum 1-year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis strongly preferred 

•    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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