QC Associate Scientist

Full Time

Concord, OH, US

Associate Scientist, QC

Department: Quality

Position Summary

We are 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.