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QC Chemist III

1 month ago

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

Join Cipla as a QC Chemist III and contribute to the development of high-quality pharmaceutical products.

Job Summary:

We are seeking a highly skilled and experienced QC Chemist III to perform analytical testing for Raw Materials, Finished and In-Process of Drug Substances and Products. The successful candidate will be responsible for executing method validations, developing efficient analytical procedures, and drafting/reviewing laboratory SOP's.

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.
  • 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.
  • Maintain QC lab related systems to ensure compliance with industry standards.
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.
  • 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).
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, per year.