Engineering QMS Lead – GMP Documentation & Compliance

Tailstorm-Health-Inc; Chandler (AZ); On-site; USD 81,000 - 99,000; Full time

Job summary

Tailstorm-Health-Inc in Chandler, AZ, seeks an Engineering QMS Manager to support the quality management system within a 503B sterile injectable facility. You will coordinate deviations, CAPAs, change controls, PM and calibration records, ensuring timelines and GMP compliance.

In this middle-management role, you will work with Engineering, QA, Production, QC/Microbiology, Validation, and other departments to maintain controlled documents, perform reviews, and escalate delays while upholding

Qualifications

• Bachelor's degree or diploma in a relevant technical field.
• 0–8 years of experience in regulated manufacturing.
• Strong documentation and organizational skills.
• Good written and verbal communication.

Responsibilities

• Support deviations, CAPAs, change controls and other QMS records.
• Assist with collecting information for deviation investigations.
• Maintain QMS trackers and escalate overdue activities.
• Coordinate evidence for QMS closure and review QA comments.
• Support GMP documentation and validation-related activities.
• Assist with SOPs and controlled documents management.

Skills

Technical writing

Documentation

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Tailstorm-Health-Inc in Chandler, AZ, seeks an Engineering QMS Manager to support the quality management system within a 503B sterile injectable facility. You will coordinate deviations, CAPAs, change controls, PM and calibration records, ensuring timelines and GMP compliance.

In this middle-management role, you will work with Engineering, QA, Production, QC/Microbiology, Validation, and other departments to maintain controlled documents, perform reviews, and escalate delays while upholding