QC Chemist III

1 week ago

Central Islip, New York, United States Cipla Full time
Job Title: QC Chemist III

Cipla is seeking a highly skilled QC Chemist III to join our team in Central Islip, NY. As a key member of our Quality Control department, you will be responsible for performing analytical testing for Raw Materials, Finished and In-Process of Drug Substances and Products.

Key Responsibilities:
  • Perform analytical testing for Raw Materials, Finished and In-Process of Drug Substances and Products.
  • 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.
  • Collaborate with cross-functional teams to ensure compliance with industry standards.
  • Develop efficient and selective analytical procedures and draft/review laboratory SOP's.
  • Identify discrepancies, initiate, and investigate OOS/OOT results.
  • Perform timely and accurate peer review of analytical test results report/document in notebooks.
Requirements:
  • Master of Science Degree in Chemistry, Pharmaceutical Sciences, or related field.
  • One (1) year of experience in the field of Drug Safety and/or Quality Control.
  • Experience in analyzing and monitoring stability of studies of drug products under various stability conditions for any out of trend in the product.
  • 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.
  • Knowledge using instruments such as: HPLC, UV/VIS, Dissolution (USP-I, II & III) and FTIR.
  • Experience in operating, troubleshooting of various analytical instruments.
Working Conditions:

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.

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