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Job description
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.