Quality Assurance Lead in Waltham, MA

  • Title: Quality Assurance Lead
  • Code: RCI-09168
  • RequirementID: 121726
  • Location: Waltham, MA 02451
  • Posted Date: 10/09/2024
  • Duration: 12 , extension possible based on needs and performance
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  Job Description

Hybrid

 

Duties:

  • 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.
  • Perform QA review and approval on SOPs, forms, WI, and other document types
  • Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities

 Minimum Education:

  • HS or AA degree, with 8+ years of experience
  • Bachelors and or 5+ years of experience
  • Minimum of 5 years of experience must be in quality, more experience welcomed
  • Reviews and Approves Analytical related documents such as Test Methods, Test Method, Transfer Plans and Assessments.

 Must Have:

  • Industry Knowledge, only support QC lab documentation, testing - will not support manufacturing Reviews and Approves Analytical related documents such as Test Methods, Test Method, Transfer Plans and Assessments.
  • 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.
  • MS Office

 Nice to Have:

  • Veeva experience a plus!
  • Experience as QA Lead on projects


About Rangam:

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.

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