1-844-554-3239

Quality Assurance Associate

Mequon, WI
Full-time


We are excited to announce a brand-new position in our Quality Assurance department at MPP Group, LLC!This position will provide QA oversight and support to 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)
  • Administer, track, and manage document control activities, such as issuing change requests, drafting and reviewing procedures, test methods, specifications, protocols, and reports, implementing change, and finalizing documents.
  • Provide Quality review 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.
  • Disposition of product, including review of final product testing and creation of COAs.
  • Provide training when needed on the Quality Management System.

Requirements:

Bachelor’s degree and 2+ years of experience in a biotech, pharmaceutical, or similarly regulated industry, 2-3 years’ experience in analytical chemistry and/or drug related products preferred, and 1+ years of leadership experience directly related to Quality Management.

  • Experience in a broad range of Pharmaceutical/Medical Device Quality Assurance, including operational quality, management of R&D quality, and development of Quality Systems is a must.
  • Ability to apply scientific knowledge and understanding of the industry regulations to applicable internal issues.
  • Excellent communication skills (verbal and written) with Management, outside clients, colleagues, peers, and regulatory agencies.
  • Strong leadership and personnel development experience.
  • Strong working knowledge of 21 CFR 210/211 as well as general knowledge of 21 CFR 820 Quality Systems. Dietary Supplement 21 CFR 111 a plus.
  • Ability to work under challenging deadlines and be accountable for completing work within specified time periods
  • Ability to manage and prioritize projects
  • Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.

Job Type: Full Time

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