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QC Contractor

Cambridge, MA 02139

Posted: 11/15/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 522695 Is job remote?: No Country: United States

Job Description

Duties: Represent Quality Control in a highly matrixed, cross functional environment. Support establishment of Quality Control systems to support commercial activities. Support stability program(s) through tracking of stability pulls, internal data summaries, and preparing data for statistical and preparing data for statistical analysis. Support activities to streamline data review, stability data reporting, stability protocols and reports across external labs. Pro-actively seek out updates from external laboratories and ensure internal records are maintained for stability. Help to establish on time performance metrics for stability report preparation and track on time stability testing. Review / approve method validation protocols, reports, as applicable for INT, DS and DP. Data review for CTM batch release (including API, drug product intermediate, and drug product data review). Provide support for OOS/OOT investigations, and External Laboratory Deviations by entering in eQMS. Manage reference materials inventory (i.e., inventory levels, synthesis and qualification, and requalification. Perform Data Integrity review of CMC sections of regulatory submissions (i.e., IND and IMPD).
 
Skills: Planning and organizational skills - Ability to effectively prioritize and manage multiple projects and tasks Communication and Teamwork - Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals Clear communicator, able to work collaboratively with internal and external stakeholders and able to express ideas effectively in both written and oral contexts
 
Education:
  • A BS Degree in Chemistry, Biochemistry, Biology or a related discipline with 3+ years of relevant industry experience
  • Experience in a GMP laboratory including QC drug substance and drug product stability, preferably small molecule experience
  • Experience preparing stability protocols and reports, including statistical analysis of data
  • Experience in OOS/OOT resolution, root cause analysis tools, and monitoring effectiveness of CAPAs
  • Good working knowledge of ICH stability guidelines
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