Life Sciences Validation & Quality Systems Consultant

Critical Mass Consulting, LLC

Los Angeles (CA)

Sur place

USD 90 000 - 120 000

Plein temps

14 jours+

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Résumé du poste

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).

Responsabilités

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.