Chemist

Business:
Pharma Solutions
Department:
Analytical Quality Control (AQC)

Location:

Lexington

This position reports to the AQC Group Lead.

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.

• 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

• 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