Senior Analytical Chemist

Integrated Resources, Inc ( IRI ); Raleigh (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Integrated Resources, Inc (IRI) in Raleigh, NC seeks an Analytical Chemist to join its Quality Control team. The role focuses on routine and non-routine raw material testing, using HPLC, GC, UV/Vis and other QC instruments to ensure compliance with USP and internal procedures.

You will work with LIMS/Empower, review data, identify OOS events, and contribute to CAPA activities while maintaining GDP/GMP standards in a fast-paced pharmaceutical environment.

Qualifications

• Bachelor’s degree in Chemistry or a related field; BS in Chemistry preferred.
• 3–5 years of experience in the pharmaceutical industry.
• 2–4 years hands-on analytical testing in a QC lab.
• Experience with generic pharmaceutical manufacturing/testing preferred.
• Working knowledge of USP, ICH, and FDA requirements.
• Strong GDP and GMP knowledge.
• Hands-on experience with HPLC, GC, UV-Vis, IR, KF titration, particle size analysis, and other QC tests.

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.

Skills

Attention to detail

Troubleshooting

Independent work

Documentation skills

Quick learner

Education

Bachelor's degree in Chemistry

BS in Chemistry preferred

Tools

LIMS

Empower

HPLC

GC

UV-Vis

IR

KF titration

Particle size analyzer

Job description

• 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.