Quality Systems & Documentation Lead

Sanisure; Camarillo, Northern (CA, KY); Hybrid; USD 70,000 - 75,000; Full time

Job summary

SaniSure, a biotech manufacturer in Camarillo, seeks a Quality Systems Specialist to maintain the QMS and manage controlled quality documentation, including SOPs, specs, and validation guides. You will collaborate with Quality, Engineering, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accuracy and compliance.

The role requires 3+ years in quality systems within regulated manufacturing, experience with CAPA and risk management, and strong attention to detail to drive

Qualifications

• 3+ years' experience in quality systems within regulated manufacturing.
• Experience with risk management tools (FMEA) and CAPA methodologies.
• Working knowledge of QMS principles and document-control practices.
• Experience developing, reviewing, maintaining, and implementing controlled documents.
• Ability to coordinate information from multiple internal and external sources.
• Experience with audits, supplier qualification, and quality improvement activities.

Responsibilities

• Develop, review, approve, and maintain controlled quality and technical docs.
• Coordinate collection and verification of product and component info.
• Ensure documentation reflects approved configurations and specs.
• Maintain revision history, templates, workflows, and release processes.
• Support audits and CAPA activities and supplier qualification.
• Monitor quality trends and drive QMS improvements.

Skills

Quality systems

CAPA/root cause

FMEA risk management

Document control

Cross-functional collaboration

Education

Bachelor's degree in biological sciences, engineering, or related technical field

Job description

SaniSure, a biotech manufacturer in Camarillo, seeks a Quality Systems Specialist to maintain the QMS and manage controlled quality documentation, including SOPs, specs, and validation guides. You will collaborate with Quality, Engineering, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accuracy and compliance.

The role requires 3+ years in quality systems within regulated manufacturing, experience with CAPA and risk management, and strong attention to detail to drive