Quality Manager

1 day ago


Swedesboro, United States EPM Scientific Full time

Title: Quality Manager

Location: Albany, OH (Can Provide Relocation)

A leading pharmaceutical company just launched a brand new 503b facility and is rapidly expanding their site. They are looking for a Quality Manager to lead QA and QC activities for this new site.

Responsibilities:

  • Review and approve Quality documentation (batch records, SOPs, deviations, change controls, OOS investigations, etc.)
  • Create annual product reviews, review/approve label changes
  • Provide assistance and leadership in regulatory inspections
  • Oversee incoming materials, sample reserve, and sterility assurance programs
  • Support vendor management and assist with vendor qualification activities
  • Host FDA audits and Regulatory inspections

Qualifications:

  • Bachelor's degree with 7+ years of relevant experience
  • Ability to lead QA/QC activities and work in a fast-paced startup environment
  • Must have experience with batch disposition and sterility
  • Must have experience hosting FDA audits and regulatory inspections

If this sounds of interest, please don't hesitate to apply



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