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Quality Assurance Associate

Company: Michael Page
Location: Waltham
Posted on: June 1, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Summary

This role is responsible for the Quality review of manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing.

Client Details

Our client is a top bioprocessing manufacturer that develops and commercializes equipment used in development of biologics.

Description

  • Perform batch record review; to include review of production records, quality control records such as (i.e.: monthly RO/DI, weekly Environmental Monitoring records), and weekly/monthly logs.
  • Identification of process deviations.
  • Identification of Out-of-Specifications (OOS) results.
  • Label Verification.
  • Assist with the maintenance of QMSu
  • Bind and file completed batch records and other administrative activities

Profile

  • Bachelor's degree in Biological Science or other science related discipline.
  • Minimum 1+ years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
  • Ability to communicate with multiple departments and associates.
  • Shares timely information with peers on daily progress.
  • Ability to contribute to project teams.
  • Focus and attention to detail is critical
  • Understanding of Good Documentation Practices preferred

Job Offer

  • Competitive base salary and compensation package
  • Excellent career development and growth

Keywords: Michael Page, Waltham , Quality Assurance Associate, Other , Waltham, Massachusetts

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