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
Job Title
Chemist I