Senior QC Chemist - HPLC/GC & cGMP Expert

Piramal Pharma Limited; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, USA, is seeking a Chemist II for Analytical Quality Control. The role performs complex testing of raw materials, in-process and finished products, and maintains instruments per cGMP standards.

You will train entry-level QC personnel, document procedures, and ensure compliance with GDP/cGMPs while contributing to a clean, organized lab environment and accurate data reporting.

Qualifications

• Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
• Minimum 5+ year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis
• Function as the team SME with regard to chemist duties and overall testing knowledge; provide team support as needed
• Previous experience working within cGMP guidelines
• 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; able to manage conflicting priorities
• Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility
• Excellent problem solving, communication, and interpersonal skills
• Ability to follow and can also explain to others written instructions and procedures.

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.

Skills

Excellent communication skills

Detail oriented

Team SME

Problem solving

Interpersonal skills

Education

Bachelor of Science in Chemistry or Pharmaceutical Science

Tools

HPLC/GC analysis

Job description

Piramal Pharma Solutions in Lexington, USA, is seeking a Chemist II for Analytical Quality Control. The role performs complex testing of raw materials, in-process and finished products, and maintains instruments per cGMP standards.

You will train entry-level QC personnel, document procedures, and ensure compliance with GDP/cGMPs while contributing to a clean, organized lab environment and accurate data reporting.