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QA Specialist

Lafayette $75,000-$100,000 Contract

Job Responsibilities:

  • Promote cross-functional interactions to achieve quality outputs and to improve the CRMS

  • Provide vision, direction, development, and leadership to the Quality Assurance Team

  • Engage with Quality leadership to ensure development continues to be responsive to changing quality expectations

  • Formulates a justifiable stance on regulatory issues, articulating it with compelling reasoning and adapting the writing style to suit the intended audience.

  • Compiles documentation for submission to regulatory agencies.

  • Keeps meticulous records of technical documents dispatched to regulatory bodies.

  • Creates well-structured, comprehensive, and persuasive position papers or statements when necessary.

  • Drafts responses to inquiries or shortcomings raised by regulatory agencies.

  • Devises and executes regulatory strategies for both new and current products.

  • Acts as a company liaison to the FDA and foreign regulatory entities when necessary, both internally and externally.

Qualifications:

  • BS in relevant field (MS preferred)

  • Minimum of 3 years professional experience is required

  • Maintains knowledge of requirements applicable to the performance of regulatory affairs and QA tasks.

  • Excellent oral, written, computer and interpersonal skills

  • Assures quality requirements are met Microsoft Office Suite and Project

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