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Quality Control Data Reviewer

4 weeks ago

Boston, Massachusetts, United States AVEO Oncology Full time
About the Role

Aveo Oncology is seeking a detail-oriented Quality Control Data Reviewer to support our commitment to excellence in oncology data management.

Key Responsibilities
  • Manage iStability software by submitting and maintaining all stability data available up to date for clinical development candidates and commercial materials in Aveo's product portfolio.
  • Review and approval of stability data entries against raw data and iStability studies for accuracy, completeness, and compliance with regulatory standards, where applicable.
  • Identify discrepancies, trends, and anomalies in data sets, and work with technical operation applicable teams to investigate and resolve issues.
  • Review of stability protocols and reports and keep track of the pull dates.
  • Review of analytical validation protocols, reports, and raw data and support in identifying and resolving any discrepancies and/or deviations.
  • Review of vendor raw data available for clinical development candidates and commercial materials in Aveo's product portfolio in a timely manner.
  • Review of external and/or internal analytical documents associated with Aveo's product portfolio.
  • Reviews regulatory documentation supporting drug substance or drug product sections for INDs, NDAs, MAAs, etc.
  • Assure that all aspects of stability operations comply with applicable SOPs.
  • Review and/or revision of internal SOPs related to stability, specifications, and data review as applicable.
  • Collaborate with cross-functional teams, including Technical Operations, Quality Assurance, and Regulatory Affairs, to support clinical programs and commercial products.
  • Assist in training staff on iStability when required.
  • Stay informed about industry trends, regulatory updates, and best practices related to stability data management.
Requirements
  • Requires a BS/BA in Chemistry, Biochemistry, or equivalent scientific discipline.
  • 1-3 years' experience in performing stability studies in a pharmaceutical/biopharmaceutical laboratory under regulated environment.
  • Strong background on iStability software.
  • Familiarity with cGMP, USP/EP, ICH, and FDA/EMEA regulations for biopharmaceutical products.
  • Knowledgeable in the analytical methodologies utilized for small molecules and/or monoclonal antibodies for early clinical through late stage/commercial manufacturing.
  • Written and verbal communication skills.
  • Proficiencies with Microsoft Office and associated applications.
  • Attention to detail and the ability to work independently and as part of a dynamic team environment with minimal supervision.