Deviation Investigation Specialist

Praxis PackagingKentwood, MI
$55,000 - $75,000

About The Position

Join a critical role at the intersection of quality, compliance, and operations. As a Deviation Investigation Specialist, you'll lead root cause investigations, develop clear and compliant technical documentation, and partner with cross-functional teams to drive continuous improvement in a fast-paced contract packaging manufacturing environment.

Requirements

  • High school diploma or equivalent required.
  • 2-4 years plus similar experience required.
  • Strong GDP/GMP experience required.
  • Basic Mechanical and mathematical aptitude required.
  • The ability to work independently, without supervision required.
  • Ability to organize priorities and workload required.

Nice To Haves

  • Associates Degree or equivalent combination preferred.
  • Lead/Group Leader experience preferred.

Responsibilities

  • Investigates deviations related to Primary Production.
  • Facilitates TW change controls related to Primary Production.
  • Serves as backup to the Primary Production manager in any TW related meetings or cases.
  • Assists with management of assigned projects.
  • Ensures projects are completed by established deadlines.
  • Contributes as subject matter expert (SME) in applicable projects related to Primary Production.
  • Adherence to all Company policies and procedures.
  • Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
  • Provides assistance and answers a diverse workforce of 5-10 employees.
  • Instills a sense of quality through modeled quality behaviors and mindset.
  • Assists with Training and Orientation.
  • Ensures employees are trained according to their roles.
  • Elevates complaints and problems, seeks Management assistance.
  • Ensures proper PPE’s and Safety procedures are followed.
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