Engineering QMS Lead - Documentation & Compliance

Medivant Healthcare; Chandler (AZ); On-site; USD 81,000 - 99,000; Full time

Job summary

Medivant Healthcare in Chandler, AZ seeks an Engineering QMS Manager to support Quality Management System activities within a 503B sterile injectable manufacturing facility. This middle-management role collaborates with Engineering, QA, Production, QC, Validation and other departments to ensure timely completion of deviations, CAPAs, change controls and related GMP records.

You will maintain QMS trackers, assist with investigations, coordinate change controls, preventive maintenance,

Qualifications

• Bachelor's degree or diploma in engineering or related technical discipline.
• Proven understanding of cGMP principles and pharmaceutical Quality Management Systems.
• Strong technical writing, documentation, organizational, and follow-up skills.

Responsibilities

• Support initiation, documentation, tracking, and closure of Engineering deviations, CAPAs, change controls, action items, and other QMS records.
• Assist Engineering personnel with deviation and investigation documentation.
• Maintain Engineering QMS trackers and monitor due dates.
• Coordinate with Engineering to obtain supporting evidence for QMS closures.
• Assist in responding to QA comments and documenting review observations.
• Escalate overdue QMS activities to Engineering management.

Skills

cGMP knowledge

Technical writing

Documentation management

Cross-functional collaboration

Attention to detail

Reading engineering drawings

MS Word

MS Excel

MS Outlook

Education

Bachelor's degree or diploma in Mechanical, Electrical, Instrumentation, Chemical Engineering, Biotechnology, Pharmaceutical Sciences or related technical discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Medivant Healthcare in Chandler, AZ seeks an Engineering QMS Manager to support Quality Management System activities within a 503B sterile injectable manufacturing facility. This middle-management role collaborates with Engineering, QA, Production, QC, Validation and other departments to ensure timely completion of deviations, CAPAs, change controls and related GMP records.

You will maintain QMS trackers, assist with investigations, coordinate change controls, preventive maintenance,