Manufacturing QMS Associate

Tailstorm-Health-Inc; Chandler (AZ); On-site; USD 41,000 - 50,000; Full time

Job summary

Tailstorm-Health-Inc in Chandler, AZ is seeking a Manufacturing QMS Associate to support Quality Management System activities. The role focuses on managing change controls, deviations, CAPAs, investigations, SOP documentation, and ongoing improvement while ensuring compliance with regulatory requirements.

You will initiate and review change controls via Master Control, draft investigations, prepare SOPs, and collaborate with cross-functional teams to train on cleanroom standards and

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• 2-4 years of experience in Quality Systems, Manufacturing or GMP 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 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

Quality Systems

Change Control

CAPA

Deviations

SOP Documentation

Investigations

Training

Education

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

Tools

MasterControl

QMS Documentation

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manufacturing QMS Associate

Full Time Chandler Chandler, AZ, US

5 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.