Quality Validation Technician – Aseptic Pharma

McGuff Pharmaceuticals, Inc.; Santa Ana (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is seeking a Pharmaceutical Quality/Validation Technician to join Quality Engineering and Validation.

You will plan, organize and perform commissioning, qualification and validation for processes, facilities, equipment and controls, and maintain the requalification program. The role includes IQ/OQ/PQ, PPQ, sterile processing validation, environmental monitoring and process improvements to meet cGMP standards.

Qualifications

• 2 year technical degree required; BA/BS a plus.
• Experience in pharmaceutical/biotech, especially sterile injectable manufacturing.
• Proficient with computer software and data systems; GMP knowledge required.
• Good written and verbal communication; ability to work independently and in a team.
• Knowledge of ISO 9000 is a plus.

Responsibilities

• Maintain and execute qualification/validation protocols (IQ/OQ/PQ).
• Plan, coordinate and perform validation for processes, equipment and facilities.
• Support requalification program and documentation of validation activities.
• Develop SOPs and participate in risk analyses as assigned.
• Ensure compliance with cGMP and project-specific requirements.

Skills

Communication skills

Independent work

Team player

Multitasking

Typing

Statistical techniques

Education

Two-year technical degree

Bachelor's degree preferred

Tools

Kaye Validator

Microsoft Office Professional

Job description

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is seeking a Pharmaceutical Quality/Validation Technician to join Quality Engineering and Validation.

You will plan, organize and perform commissioning, qualification and validation for processes, facilities, equipment and controls, and maintain the requalification program. The role includes IQ/OQ/PQ, PPQ, sterile processing validation, environmental monitoring and process improvements to meet cGMP standards.