Life Sciences Validation & Quality Systems Consultant

Critical Mass Consulting, LLC; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Critical Mass Consulting, LLC is seeking a Life Sciences Technical Consultant to join our Los Angeles team. You will develop and execute commissioning/validation protocols and support FDA-regulated projects across client sites in the LA area.

Ideal candidates have 2+ years in pharma/biotech, strong technical writing, GDP knowledge, and familiarity with no-code BI tools. We offer a start-up environment with mentorship and growth opportunities.

Qualifications

• Belief in core values and a culture of collaboration.
• 2+ years of experience in pharmaceutical, medical device or biotech industries.
• Excellent written and verbal communication with strong technical writing skills.
• Strong understanding of GDP and experience in FDA-regulated environments.
• Proficiency with no-code BI tools is a plus (Power BI, Tableau, Looker).

Responsibilities

• Develop and execute commissioning/validation protocols (FAT, SAT, IQ/OQ/PQ) for critical systems.
• Develop and perform risk analyses for validation projects.
• Support multiple client sites on validation projects in the Los Angeles area.
• Help develop internal processes to improve quality of delivery and team engagement.
• Consult clients on commissioning, qualification and validation best practices.
• Develop standards and best practices for development and validation activities.
• Manage medium-small teams and/or projects.
• Participate in team-based projects in Quality Systems and Validation for life sciences clients.
• Establish or maintain quality systems including Change Control, Deviations, and CAPAs.
• Advise clients on latest industry approaches to commissioning, qualification and validation.

Skills

Passion for Life Sciences

Strong communication skills

GDP knowledge

FDA-regulated industry experience

No-code BI tools (Power BI, Tableau, L

Tools

Power BI

Tableau

Looker

Job description

Critical Mass Consulting, LLC is seeking a Life Sciences Technical Consultant to join our Los Angeles team. You will develop and execute commissioning/validation protocols and support FDA-regulated projects across client sites in the LA area.

Ideal candidates have 2+ years in pharma/biotech, strong technical writing, GDP knowledge, and familiarity with no-code BI tools. We offer a start-up environment with mentorship and growth opportunities.