Senior Specialist, Regulatory Compliance

2 days ago


Cambridge, Massachusetts, United States Scholar Rock Full time

Scholar Rock is a biopharmaceutical company that discovers, develops and delivers life-changing therapies for people with serious diseases. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily, the clinical-stage company is focused on advancing innovative treatments where protein growth factors play a transformational role.

The Senior Specialist will support the Quality Assurance department in planning, executing and managing outsourced contract manufacturing organizations (CMOs). The individual will assist in lot disposition, manage GMP activities and assure quality and compliance initiatives are optimized and executed appropriately.

Key Responsibilities:

  • Review and approval of Master Batch Records from CMOs
  • Review of executed batch records from CMOs
  • Perform lot disposition
  • QA support to contract manufacturing operations
  • Track/maintain metric logs related to lot release
  • Assist with SOP writing and revisions, investigation and deviation activities, and CAPAs
  • Assist with change controls, including Change Control Review Board and manage change control records

Requirements:

  • Bachelor's Degree preferred
  • 3-5 years of experience with general Quality Systems in a regulated environment
  • Proven ability to work independently and handle multiple priorities
  • Ability to maintain confidentiality of proprietary information
  • A good team player with initiative to complete tasks diligently and correctly
  • Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements


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