QC Compendial Specialist
King of Prussia, PennsylvanieÉtats-Unis
6d ago

Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance?

If so, this QC Compendial Specialist could be an exciting opportunity to explore.

As a QC Compendial Specialist, you are a subject matter expert of pharmocoepial compendia within PSC UMBL, ensures compliance with compendia, and helps align compendial processes and procedures within PSC.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :

  • Authors and updates compendial testing methods and procedures in compliance with all regulations (domestic and international), cGMP's, cGLP's, and corporate requirements.
  • Provides Subject Matter Expertise in all applicable pharmocoepia USP / NF, EP, JP, ChP, BP, etc.
  • Supports electronic data management, including ERP and LES.
  • Manages initiatives to improve Quality Operations overall laboratory operational efficiency and GMP performance.
  • Reviews data as needed
  • Performs appropriate GMP training
  • Author and review compendial sections of regulatory filings as needed.
  • Manages analytical technical transfers and method validation timelines and resourcing.
  • Generates business metrics to measure testing performance.
  • Responsible for the management and final approval of all related deviations / investigations.
  • Participates in regulatory audits, agency inspections and the site internal auditing program.
  • Assesses and implements pharmocoepial / compendial changes.
  • Provides support to Raw Material Specialist and Supervisor.
  • Manages external testing relationships.
  • Why you?

    Basic Qualifications :

    We are looking for professionals with these required skills to achieve our goals :

  • Bachelor’s degree
  • 5 years in related field
  • Significant knowledge of pharmocoepial requirements and compendial testing.
  • Preferred Qualifications :

    If you have the following characteristics, it would be a plus :

  • Ability to interpret data and results.
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