What are the responsibilities and job description for the Chemist II position at Piramal Pharma Solutions?
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
