Manufacturing QMS Associate

Medivant Healthcare; Chandler, Northern (AZ, KY); Hybrid; USD 41,000 - 50,000; Full time

Job summary

Medivant Healthcare in Chandler, AZ is seeking a Manufacturing QMS Associate to support quality management system activities. You will manage change controls, deviations, CAPAs, investigations, SOP documentation, and drive continuous improvement to ensure compliance with GMP and FDA requirements.

In this role you will coordinate with cross-functional teams, draft investigations, prepare SOPs, and help train staff on cleanroom practices. A BS degree and 2–4 years of GMP experience are required.

Qualifications

• BS degree or higher in a relevant field and 2–4 years in GMP or quality systems.
• Experience with change control, CAPA, deviations and SOPs.
• Familiarity with MasterControl or similar electronic QMS.

Responsibilities

• Initiate and review Change Controls, Deviations, and CAPAs through Master Control.
• Draft investigations, including OOS and deviation reports.
• Prepare and maintain SOPs and quality documents.
• Coordinate with cross-functional teams to complete QMS activities on time.
• Provide training on cleanroom requirements and manufacturing practices; support improvements.

Skills

Change Control

CAPA

Deviations

SOP Documentation

Quality Systems

GMP Compliance

Documentation Management

Process Improvement

Cross-Functional Collaboration

Attention to Detail

Education

Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field

Tools

MasterControl

Job description

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Manufacturing QMS Associate

Full Time Chandler Chandler, AZ, US

4 days ago Requisition ID: 1147

Salary Range: $45,000.00 To $45,000.00 Annually

Position Summary

The Manufacturing QMS Associate supports Quality Management System (QMS) activities by managing change controls, deviations, CAPAs, investigations, SOP documentation, and continuous improvement initiatives while ensuring compliance with quality and regulatory requirements.

Key Responsibilities

QMS & Documentation

• Initiate and review Change Controls, Deviations, and CAPAs through Master Control.
• Draft investigations, including OOS and deviation reports.
• Prepare and maintain Standard Operating Procedures (SOPs).

Cross-Functional Support

• Coordinate with cross-functional teams for timely completion of QMS activities.
• Collaborate with the Quality team for document review and approval.
• Provide training on cleanroom requirements and manufacturing practices.
• Support process improvement initiatives.
• Perform additional duties assigned by the HOD based on organizational needs.

Qualifications

Required

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• 2-4 years of experience in Quality Systems, Manufacturing, or GMP-regulated environments.
• Experience with Change Control, CAPA, Deviations, and SOP documentation.

Preferred

• Experience with MasterControl or equivalent electronic QMS.
• Knowledge of GMP, FDA, and quality compliance requirements.
• Quality Management Systems (QMS)
• Change Control Management
• SOP Development
• GMP Compliance
• Documentation Management
• Process Improvement
• Cross-Functional Collaboration
• Attention to Detail

What Success Looks Like

• QMS records are completed accurately and on time.
• Investigations, CAPAs, and change controls are well-documented and compliant.
• SOPs and quality documents are maintained effectively.
• Continuous improvement initiatives enhance compliance and operational efficiency.