Job Description

Key Responsibilities

• Perform routine and non-routine raw material testing of commercial, validation and stability samples in accordance to written methodology.
• Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC; GC, UV/Vis, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments.
• Perform testing in accordance with USP monographs, in-house methods, compendial requirements, and approved test procedures.
• Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
• Analyze data products approved specifications, notifying management of any OOS and aberrant results
• Actively participate in root cause problem solving during laboratory investigations, provide input for effective corrective and preventive actions
• Perform routine maintenance on lab equipment, as needed.
• Support troubleshooting, laboratory investigations, and discrepancy investigations under the direction of a supervisor.
• Perform peer review of laboratory testing, as required
• Prepare and/or review test procedures, SOPs, protocols, and other analytical documentation as assigned.
• Maintain compliance with all applicable regulatory, safety, and company requirements, including: Chemical waste handling and disposal, Internal laboratory procedures etc.
• Maintain a clean, organized, and compliant laboratory environment.
• Perform other duties and responsibilities as assigned.

Required Qualifications

• Bachelor’s degree in Chemistry or another relevant scientific discipline.
• A BS in Chemistry or a degree with Chemistry coursework is preferred.
• 3–5 years of experience in the pharmaceutical industry.
• 2–4 years of hands-on analytical testing experience in a pharmaceutical QC laboratory.
• Experience with generic pharmaceutical manufacturing/testing is preferred.
• Working knowledge of USP, ICH, and FDA requirements.
• Strong knowledge of Good Documentation Practices (GDP) and GMP requirements.
• Hands-on experience with analytical techniques such as HPLC, GC, UV-Vis, IR, KF titration, particle size analysis, and other routine QC testing.
• Strong attention to detail and ability to accurately document and review analytical data.
• Ability to work independently, prioritize tasks, meet established timelines, and make sound decisions.
• Ability to learn new procedures, methods, and laboratory techniques quickly.
• Strong troubleshooting and problem-solving skills.

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