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Senior Quality Assurance

Salary undisclosed

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We are looking for Senior Quality Assurance for our client in Waltham, MA
Job Title: Senior Quality Assurance
Job Location: Waltham, MA
Job Type: Contract
Job Description:
Pay Range: $80.51hr - $85.51hr
  • Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
  • Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
  • Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
  • Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.
  • Provides iShift support for GMID and BOM approval.
  • Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
  • Assume additional responsibilities as assigned.
  • Competencies/ Requirements for position
Qualifications/ Education and Work Experience:
  • Bachelor's and/or 8+ years of relevant experience.
  • Minimum 5 years of experience in Quality.
  • Working knowledge and ability to apply Quality principles and GMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
  • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations.
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
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