QC Chemist III

QC Chemist III

Posting Date:

Country: United States

State: New York

Location: Central Islip

Req Id:

QC Chemist IIIa" Central Islip, NY: Perform analytical testing for Raw Materials, Finished and In-Process of Drug Substances and Products like Related Compounds, Assay, Content Uniformity, Dissolution, Blend Uniformity, Karl Fischer Titration, and other related Physical testing for the methods using instruments HPLC, UV/VIS, Dissolution (USP-I, II & III) and FTIR. Execute Method validations of Drug Substance and Drug Products including Related Compounds, Assay,

Dissolution, Content Uniformity, Blend Uniformity as per ICH guidelines/USP /FDA requirements. Collaborative team player with excellent communication skills working in a highly dynamic, cross disciplinary environment. Develop efficient and selective analytical procedures and draft/review laboratory SOPas. Identify discrepancies, initiate, and investigate OOS/OOT results. Perform timely and accurate peer review of analytical test results report/document in notebooks. Maintain QC lab related systems to ensure compliance with industry standards.

Qualifications and Requirements:

• Applicant must have a Master of Science Degree Chemistry, Pharmaceutical Sciences, or related field
• One (1) year of experience in the field of Drug Safety and/or Quality Control.
• Must have experience in analyzing and monitoring stability of studies of drug products under various stability conditions for any out of trend in the product.
• Must have experience in validating analytical methods for assay, dissolution, and related compounds in drug substances and degradation products in drug products including precision, accuracy, recovery, linearity, robustness, LOD and LOQ by using HPLC, GC and UV Spectrophotometer as per ICH and FDA guidelines.
• Must have knowledge using instruments such as: HPLC, UV/VIS, Dissolution (USP-I, II & III) and FTIR.
• Must have experience in operating, troubleshooting of various analytical instruments.
• Demonstrate experience of different types of analytical methods including related substances, assay, dissolution, and cleaning methods for drug products (Solid orals, Liquid orals, Ophthalmic and Injectables).

40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States. Salary $78,374.00-$96,000. 00 per year.