Associate Scientist, QC

Key Responsibilities

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples.
• Operate and maintain laboratory instrumentation including HPLC, GC, Karl Fischer, FTIR, and other analytical equipment.
• Support stability programs through sample management, testing, and data generation.
• Review analytical data for accuracy, compliance, and proper documentation.
• Investigate OOS (Out-of-Specification) and OOT (Out-of-Trend) results and support CAPA activities.
• Author and review laboratory documentation, including protocols, reports, methods, and specifications.
• Support raw material sampling, testing, and release processes.
• Maintain laboratory inventory, reagents, standards, and retained samples.
• Collaborate with Quality Assurance, Manufacturing, and cross-functional teams to support product release and ongoing operations.
• Ensure compliance with cGMP, GLP, and applicable regulatory requirements.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3+ years of pharmaceutical or life sciences laboratory experience.
• Experience working in a Quality Control laboratory environment.
• Hands-on experience with HPLC and analytical testing methodologies.
• Experience working within cGMP-regulated environments.
• Strong understanding of pharmaceutical analytical techniques and laboratory documentation practices.

Preferred Qualifications

• Experience with GC, FTIR, ICP-MS, ICP-OES, XRD, DSC, TGA, or related instrumentation.
• Experience supporting stability studies.
• Knowledge of ICH guidelines and pharmaceutical quality systems.
• Experience conducting OOS/OOT investigations and root cause analysis.
• Small molecule pharmaceutical experience.

Desired Skills

• Strong analytical and problem-solving abilities.
• Excellent documentation and technical writing skills.
• Ability to manage multiple projects and priorities simultaneously.
• Strong communication and collaboration skills.
• Proficiency with Microsoft Office applications, including Excel and Word.