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Quality Control Raw Materials Scientist

Morris Plains, NJ 07950

Posted: 05/17/2023 Employment Type: Contract Job Category: Scientific Job Number: 566371 Is job remote?: No Country: United States

Job Description

Major Accountabilities:
  • Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and in-house methods
  • Perform testing on raw materials per using HPLC, GC, UV, FTIR, NIR, wet chemistry and other techniques.
  • Perform all testing and activities compliantly following appropriate SOPs and procedures.
  • Review data generated by other team members.
  • Review QC documents to ensure completeness, accuracy, consistency, and clarity.
  • Perform quality impacting assessments and make decisions.
  • Participate special projects and facilitate any issues that arise.
  • Initiate change controls.
  • Author validation documentation.
  • Independently leads investigations of the highest complexity
  • Drive complex investigations to understand root cause.
  • Participate in OOS/OOE investigation
  • Participate in deviation investigation/CAPA implementation in a timely manner
  • Responsible for evaluating compendial updates against internal methods
  • Serve as Quality Control representative on cross-functional teams.
  • Knowledge of LabWare LIMS and/or other QC data systems.
  • Knowledge of appropriate GMP/GLP quality systems (eSOPs, TEDI, etc.).
  • Plan and schedule activities.
  • Ability to lift 35lbs.

In addition to these primary duties, provide coverage for all appropriate areas.

Perform other job duties as assigned.

  • BA, or MS in biology, chemistry, biochemistry, microbiology, or other related science.
  • Experience in Analytical Quality Control, method development, or a technical support function.
  • At least 3 years of experience.
  • Thorough knowledge of raw material test methods.
  • Analytical chemistry knowledge to facilitate investigations.
Pay rate range $25-$34
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