Manufacturing QMS Associate

RXinsider LTD.; Chandler (AZ); On-site; USD 70,000 - 95,000; Full time

Job summary

RXinsider LTD. is seeking a Manufacturing QMS Associate to lead change controls, deviations, CAPAs, and investigations, ensuring compliance with GMP and regulatory requirements. You will draft SOPs and support continuous improvement across cross-functional teams.

The role involves reviewing QMS documentation, coordinating with the Quality team, and providing cleanroom training. A Bachelor’s in a related field and 2–4 years of applicable experience are preferred.

Qualifications

• 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.

Responsibilities

• 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).
• 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 as assigned by the HOD.

Skills

QMS

Change Control

CAPA

Deviation Handling

SOP Development

GMP Compliance

Documentation Mgmt

Cross-Functional Collaboration

Attention to Detail

Education

Bachelor's degree in Pharmacy/Life Sciences/ Biotechnology

Tools

MasterControl

QMS Software

Job description

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.

Continuous Improvement

• 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.

Key Competencies

• Quality Management Systems (QMS)
• Change Control Management
• CAPA & Deviation Handling
• Investigation Writing
• SOP Development
• GMP Compliance
• Documentation ManagementProcess 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.