JVT Advisors

QAV Drug Product

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Location: Cambridge, Massachusetts
Employment Type: Contract

Job Description

Contract length: 12 Months

Job Summary: The primary role of the Lead Specialist, Quality Assurance Validation will be to support the organization through the establishment of a validation/qualification program across disciplines and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. In this position you will be responsible for guidance and technical review of protocols and reports related to test methods, technology transfers, process characterization, and process validation activities.


Responsibilities:

  • Provide support and guidance for the development, execution, data analysis and reporting of external clinical and commercial protocols as necessary.
  • Provide support and guidance in the development and execution of CxO validation / qualification documentation.
  • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action
  • Ability to multitask and prioritize independently in a high paced environment.
  • QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.

Qualifications:

  • Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required.
  • Technical understanding of biopharmaceutical production. Expertise in best practices for aseptic processing and contamination control
  • A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
  • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
  • Leadership skills to lead cross functional teams to ensure project success.
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
  • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
  • Project management experience and strong analytical ability

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Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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