QC Chemist III

Cipla USA; New York, North Great River (NY, NY); On-site; USD 78,000 - 96,000; Full time

Job summary

An established industry player is seeking a dedicated QC Chemist III to join their team in Central Islip, NY. In this pivotal role, you will perform analytical testing for raw materials and finished products, ensuring compliance with industry standards and regulations. You will collaborate with a cross-disciplinary team to develop efficient analytical procedures and validate methods according to ICH and FDA guidelines. This position offers a dynamic work environment where your contributions directly impact product quality and safety. If you are passionate about quality control and have the expertise in analytical methods, this opportunity is perfect for you.

Qualifications

• Master's degree in Chemistry or related field required.
• 1+ years of experience in drug safety or quality control.

Responsibilities

• Perform analytical testing for raw materials and finished products.
• Collaborate within a cross-disciplinary team to develop analytical procedures.

Skills

Analytical Testing

HPLC

UV/VIS Spectrophotometry

Dissolution Testing

Method Validation

Troubleshooting Analytical Instruments

Education

Master of Science Degree in Chemistry

Master of Science Degree in Pharmaceutical Sciences

Tools

GC

FTIR

Job description

QC Chemist III

Posting Date: [Insert Date]

Country: United States

State: New York

Location: Central Islip

Req Id:

QC Chemist III - Central Islip, NY

Perform analytical testing for Raw Materials, Finished and In-Process drug substances and products, including related compounds, assay, content uniformity, dissolution, blend uniformity, Karl Fischer titration, and other physical tests using instruments such as HPLC, UV/VIS, Dissolution (USP I, II & III), and FTIR. Execute method validations for drug substances and drug products, including related compounds, assay, dissolution, content uniformity, and blend uniformity, in accordance with ICH guidelines, USP, and FDA requirements.

Collaborate effectively within a cross-disciplinary team, develop efficient analytical procedures, and draft/review laboratory SOPs. Identify discrepancies, investigate OOS/OOT results, and perform peer reviews of analytical reports. Maintain QC lab systems to ensure compliance with industry standards.

Qualifications and Requirements:

• Master of Science Degree in Chemistry, Pharmaceutical Sciences, or a related field.
• At least 1 year of experience in drug safety and/or quality control.
• Experience in analyzing and monitoring stability studies under various conditions for out-of-trend results.
• Experience validating analytical methods for assay, dissolution, and related compounds, including precision, accuracy, recovery, linearity, robustness, LOD, and LOQ, using HPLC, GC, and UV spectrophotometry per ICH and FDA guidelines.
• Proficiency with instruments such as HPLC, UV/VIS, Dissolution (USP I, II & III), and FTIR.
• Ability to operate and troubleshoot analytical instruments effectively.
• Experience with various analytical methods for drug products, including related substances, assay, dissolution, and cleaning methods for solid orals, liquid orals, ophthalmic, and injectables.

Work hours: Monday to Friday, 9 am - 5 pm. Must have proof of legal authority to work in the United States. Salary range: $78,374 - $96,000 annually.