What are the responsibilities and job description for the Chemist I position at Piramal Pharma Solutions?
Business: Pharma Solutions
Department: Analytical Quality Control (AQC)
Location: Lexington
REPORTING STRUCTURE:
This position reports to the AQC Group Lead.
JOB OVERVIEW:
Reporting to the AQC Group Lead, the Chemist I performs testing of raw materials, in-process and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards.
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
QUALIFICATIONS:
- Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
- 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
- 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