Manufacturing QMS Specialist: CAPA, Deviation & SOPs

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

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.