Deviation Investigation Specialist

Overview

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.

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.

Qualifications

• High school diploma or equivalent required.
• Associates Degree or equivalent combination preferred.
• 2-4 years plus similar experience required.
• Strong GDP/GMP experience required.
• Lead/Group Leader experience preferred.
• Basic Mechanical and mathematical aptitude required.
• The ability to work independently, without supervision required.
• Ability to organize priorities and workload required. Pay Range USD $55,000.00 - USD $75,000.00 /Yr.