The Senior Specialist will support the Quality Assurance (QA) department in the planning, execution and management of outsourced (Contract Manufacturing Organization – CMOs). The individual will assist in lot disposition as well as managing other GMP activities. The specialist will have responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in areas of GMP compliance. Strong organizational skills are required, as well as the ability to balance changing priorities.

Position Responsibilities:

• • Review and approval of Master Batch Records Contract Manufacturing Organizations (CMO)
  • Review of executed batch records from Contract Manufacturing Organizations (CMO)
  • Perform lot disposition
  • QA support to contract manufacturing operations (attend meetings, approval of CMO documentation)
  • Track/maintain metric logs related to lot release
  • Assist with SOP writing and revisions and other QA activities as required
  • Assist in investigation and deviation activities, and CAPAs, and provide general quality assurance support for the overall Quality System at Scholar Rock.
  • Assist with change controls including Change Control Review Board and manage change control records
  • Manage the External Notification Quality System
  • Assist with temperature excursions during shipment and storage of GMP materials
  • Provides QA guidance and recommendations in a professional and collaborative manner to internal and external stakeholders

Candidate Requirements:

• • Bachelor’s Degree preferred
  • 3-5 years of experience with general Quality Systems in a regulated environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing
  • Proven ability to work independently and effectively handle multiple priorities
  • Ability to maintain confidentiality of proprietary information expected.
  • A good team player that takes initiative to complete tasks diligently and correctly.
  • Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization.
  • Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements