QC Consultant, Analytical Sciences/QC

2 weeks ago


Fort Lauderdale, United States a Biotechnology company located in MA Full time

QC Consultant, Analytical Sciences/QC


RESPONSIBILITIES

  • Review cGMP analytical method validation documentation for GMP testing of drug substance Regulatory Starting Materials (RSM) and associated synthetic intermediates.
  • Conduct Quality Control reviews of RSM and intermediate analytical method validation raw data, summary reports, and other related analytical documents.
  • Perform technical reviews of documents, ensuring QC completeness, accuracy, and consistency with associated protocols.
  • Compile and communicate review comments and required revisions on method validation review packages to company personnel and CDMO for revision.
  • Confirm the completion of QC reviews and updates of the aforementioned packages.
  • Attend and participate in periodic vendor and company teleconferences as required.


QUALIFICATIONS

  • 5-10+ years of relevant industry experience.
  • Proficiency in using Veeva for archiving.
  • Experience in reviewing backend reports and data packages.
  • Expertise in small molecule analytics.
  • Proven ability to solve analytical and QC challenges, with a focus on small molecules.
  • Mastery of current ICH guidelines and related industry practices.
  • Strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines, with the ability to apply them to analytical method validation activities.
  • Excellent attention to detail and capability to perform efficient and thorough technical data reviews.
  • Extensive experience with small molecule analytical method validations (HPLC, GC, KF, etc.).
  • Exceptional organization, communication, and multi-tasking skills.


EDUCATION

  • B.S. in Chemistry or a related discipline.
  • Ph.D. is a plus.

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