Senior Quality Assurance Associate

Adagio Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 02/20/2021
  • Website: adagiotx.com
  • Company Address:

About Adagio Therapeutics

Developer of antibodies intended to provide an effective long-term solution for the global coronavirus challenge. The company is developing antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV-1 and additional potentially emergent coronaviruses, helping doctors with antibodies that can be used as both therapeutic and durable prophylactic treatments.

Job Description

Core competencies for potential candidates should include:

 

  • Knowledge in applying GMPs for Development, Clinical Supplies and Commercial Drug Products
  • Relationship Building
  • Strong Interpersonal Communication and Influencing Skills
  • Critical Thinking and Problem Solving
  • Shifting priorities and multitasking

 

Responsibilities: Primary role of the position is supporting the development of drug substance and drug product for a biological product.  As such, the individual must be able to interpret regulations and apply as appropriate to the phase of product development:

 

  • Review and approve relevant GMP documents, including but not limited to specifications, batch manufacturing records, stability, method and process validation documents, for compliance to Adagio’s SOPs, quality systems, and regulatory requirements
  • Work collaboratively with operations counterparts to facilitate timely and effective resolution to deviations, investigations, CAPAs, and batch record reviews
  • Provide support for commercial quality operations activities as needed
  • Partner with operations counterparts to embed value-added, fit for purpose quality into the development process
  • Build strong collaborative relationships with external partners and contract organizations
  • Lead audits of GMP service providers according to appropriate regulatory requirements, Adagio SOPs, and quality systems
  • Lead internal GMP audits against appropriate regulatory requirements, Adagio SOPs, and quality systems
  • Create/revise SOPs as required by Adagio quality systems and provide training on department-specific procedures and systems
  • Assist during regulatory inspections
  • Provide ongoing guidance and ensure compliance with established systems, process, and procedures

 

Requirements: 

 

  • B.S. degree in a related scientific discipline
  • 4-7 years of experience in pharmaceutical industry with a minimum of 4 years in QA
  • Strong knowledge and experience with ICH, USP, 21 CFR 210, 21 CFR 211, and 21 CFR 600
  • Knowledge about European regulations a plus
  • Practical experience with building Quality Systems for a virtual company is a plus
  • Commercial experience a plus
  • This position is remote, work hours are typically 9:00 a.m. to 5:00 p.m. Eastern Standard Time; there may be an occasional meeting outside of normal business hours with our international partners

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.