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Quality Control Analyst

Quality Control Analyst

Piramal Pharma SolutionsSellersville, PA, United States
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Job Overview

Performs Analytical chemistry examination testing on raw materials, finished products or stability samples in accordance with approved Standard Operating Procedures (SOPs) and valid methods. This is a safety-sensitive role.

Key Roles / Responsibilities

  • Chemical or Physical testing analysis of raw materials, finished products, stability or request samples
  • Documenting and submitting all raw data and results in LIMS
  • Preparation of reagents for chemical analysis including peer review
  • Knowledgeable in compendial (USP / EU) testing requirements and ensuring compliance per FDA 21 CFR

Experience

  • Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
  • 1 - 2 years laboratory experience, preferably in a GMP environment

    • Competencies

  • Basic knowledge of laboratory safety practices and PPE
  • Basic knowledge of cGMP
  • Basic understanding of good documentation practices
  • Understanding of compendial testing requirements
  • Preferred experience with FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions.

    • Physical Requirements

  • Lift / move up to 10 lbs. and occasionally 25 lbs.
  • Individual may be required to handle hazardous and non-hazardous materials.
  • Individual may be required to wear Personal Protective Equipment.
  • Not allergic to chemicals or biosubstances found in the laboratory or production facilities.
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    Quality Control Analyst • Sellersville, PA, United States

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