Associate Scientist, QC
planet pharmaConcord (OH)
About the role
Position Summary:
Seeking a detail-oriented and proactive Associate Scientist, QC to support quality control and stability testing activities within a cGMP-regulated pharmaceutical laboratory. This role is responsible for performing analytical testing of raw materials, in-process samples, finished products, and stability samples; generating and reviewing analytical data; supporting laboratory investigations; and ensuring compliance with applicable regulatory requirements. The ideal candidate will have experience working with small molecule drug substances and drug products in cGMP and GLP environments.
Essential Responsibilities:
Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using techniques such as HPLC, GC, KF, FTIR, XRD, DSC, TGA, PSD, NMR, ICP-MS, ICP-OES, and other laboratory instrumentation as required. Support stability programs through sample management, stability chamber monitoring, testing, and generation of stability data. Coordinate timely and compliant generation of analytical data to support client projects and manufacturing operations. Review laboratory data for technical accuracy, completeness, compliance, and adherence to good documentation practices. Conduct OOS, OOT, and laboratory investigations and support implementation of corrective and preventive actions (CAPAs).Author and review protocols, reports, specifications, analytical methods, and related laboratory documentation. Perform raw material sampling, testing, inspection, and coordination activities as required. Manage laboratory inventory, retained samples, reagents, standards, chemicals, and associated laboratory systems. Collaborate with Quality Assurance, Manufacturing, and Clients to support analytical testing, batch release, and stability studies. Maintain compliance with cGMP, GLP, ICH, FDA, EMA, and other applicable regulatory requirements. Other duties as assigned.
Qualifications
Education and Experience:
Bachelor's degree in Chemistry or a related scientific discipline required. Minimum of 3 years of related pharmaceutical analytical laboratory experience with a B.S. degree, or 1 year with an M.S. degree, or an equivalent combination of education and experience. Relevant experience in a Quality Control laboratory is required. Experience working in a cGMP and/or GLP-regulated environment is required. Skills and
Competencies:
Proficiency with standard laboratory equipment, including HPLC, KF, XRD, PSD, analytical balances, pipettes, pH meters, and titration systems is required. Experience with GC, FTIR, UV-Vis, DSC, TGA, IC, ICP-MS, and ICP-OES is preferred, but not required. Experience with assay, impurity, raw material, and stability testing. Familiarity with ICH stability guidelines and pharmaceutical quality systems. Experience conducting OOS/OOT investigations and root cause analysis preferred. Strong proficiency in Microsoft Word and Excel. Strong written and verbal communication skills and the ability to work effectively with clients and cross-functional teams. Ability to manage multiple priorities and work effectively in a fast-paced environment. Strong understanding of chemistry principles, data analysis, and basic statistical concepts.
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