1-844-554-3239

Quality Assurance Associate

Mequon, WI
Full-time


MPP Group, LLC is pleased to announce a new opening in the Quality Assurance Department.

We are looking for an individual having a chemistry/pharmacy degree, willing to get hands-on training and become a QA associate and continue expanding her/his experience in supporting FDA regulated products (API, Drug Product, Medical Device, and Dietary Supplements) in a GMP environment.

Primary job responsibilities will include:

  • Establishing documentation required for the implementation and maintenance of quality systems and compliance to applicable standards (21 CFR 111, 21 CFR 820, and 21 CFR 210/211 FDA regulations)
  • Administering, tracking, and managing document control activities, such as issuing change requests, drafting and reviewing procedures, test methods, specifications, protocols, and reports, implementing change, and finalizing documents.
  • Quality reviewing and approvals as designated including, but not limited to, SOPs, Protocols, Validation, Change Controls, Master Production Records, Batch Production Records, Specifications, Stability Results and Reports, Investigations, Deviations, CAPAs and Equipment Qualification.
  • Formalizing disposition of products including review of final product testing and creation of COAs.
  • Provide training on the Quality Management System.

Requirements:

Bachelor’s degree in life chemistry or pharmacy and 2+ years of experience in a biotech, pharmaceutical or analytical chemistry environment.

  • Be a good technical writer.
  • Be a quick learner and create the documents by “writing right the first time.”
  • Be very accurate and able to critically interpret lab and production data.
  • Be thorough in writing and reviewing reports, validations, SOPs, etc.
  • Have excellent communication and interpersonal skills.
  • Have working knowledge of 21 CFR 210/211 and other Quality Systems. Familiarity of Dietary Supplement 21 CFR 111 is a plus.
  • Have ability to work under challenging deadlines and be accountable for completing work within specified time periods
  • Be able to manage and prioritize projects.
  • Have advanced computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.

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