Senior Analytical Chemist

Integrated Resources, Inc ( IRI ); Raleigh (NC); Presencial; USD 60 000 - 90 000; Tempo integral

Resumo da oferta

Integrated Resources, Inc. (IRI) in Raleigh, NC seeks a qualified analytical scientist to perform routine and non-routine testing of raw materials and samples, applying USP monographs and in-house methods with HPLC, GC, UV-Vis, and related QC instruments.

You will document results in LIMS/Empower, analyze data, and support investigations and CAPAs in a regulated GMP environment. A chemistry degree and pharma QC experience are required.

Qualificações

• Bachelor's degree in Chemistry or related field required.
• 3-5 years of pharmaceutical industry experience.
• 2-4 years hands-on analytical testing in pharmaceutical 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 analytical techniques such as HPLC, GC, UV-Vis, IR, KF titration, particle size analysis.
• Strong attention to detail and documentation.

Responsabilidades

• Perform routine and non-routine raw material testing of commercial, validation and stability samples.
• Perform qualitative and quantitative analyses using analytical instrumentation (HPLC, GC, UV/Vis, etc.).
• Test according to USP monographs, in-house methods, compendial requirements, and approved procedures.
• Use LIMS and Empower for data acquisition and processing.
• Analyze data and notify management of OOS and aberrant results.
• Participate in root-cause investigations and CAPA input.
• Maintain lab equipment; perform routine maintenance.
• Support troubleshooting and discrepancy investigations under supervision.
• Peer review laboratory testing as required.
• Prepare/review test procedures, SOPs, protocols, and other documentation.
• Maintain compliance with regulatory and safety requirements; keep the lab clean and organized.
• Perform other duties as assigned.

Conhecimentos

Attention to detail

Documentation skills

Analytical thinking

Troubleshooting

Independent worker

Time management

Learning agility

Formação académica

Bachelor's degree in Chemistry

BS in Chemistry or chemistry coursework

Ferramentas

HPLC

GC

UV-Vis

IR

KF titration

Particle size analysis

LIMS

Empower

Descrição da oferta de emprego

• 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.