Quality Assurance

  • location: Cambridge, MA
  • type: Contract
  • salary: $65.95 - $77.58 per hour
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job description

Quality Assurance

Quality Manager

Job Responsibilities

  • Provides comprehensive review of all types of bioanalytical documentation, such as protocols, SOPs, test methods, data, and reports, including QC and verification of all references and source data, through collaboration with BBD scientists, to achieve the highest quality from technical and compliance perspectives
  • Responsible to maintain and update internal departmental procedural guidances
  • Ensures regular, on-going communication with BBD, Regulatory Submissions, and Compliance colleagues to prioritize review of documentation to meet project timelines
  • Responsible for tracking latest regulatory guidance and white papers regarding all bioanalytical assays and facilitates the implementation of these new requirements within BBD by effective communication and gate-keeping the related SOPs, validation and sample analysis reports and other documentation
  • Coordinates submission of all BBD documents (e.g. qualification, validation and sample analysis reports), whether generated internally or by CRO partners, to appropriate functions for financial tracking and archiving
  • Responsible for maintaining and tracking internal departmental documents such as memos and method development reports, and for coordinating their final archiving
  • Develops training materials and ensures that all members of BBD understand the design and use of departmental SharePoint sites and server sites
  • Assists in writing of regulatory submission documents and key scientific publications
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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