AI-Driven QA Specialist - GMP/Biotech Quality

Oncotelic; San Diego (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

High-impact role with visibility across R&D and Clinical programs

Collaborative, science-driven culture

Cutting-edge AI platform influence

Job summary

A next-generation biotech organization in California is seeking a QA Specialist to support its GxP quality framework using innovative AI tools. This role offers unique responsibilities such as managing GMP/GxP SOPs and translating regulatory guidance into actionable procedures. The ideal candidate will have a Bachelor’s degree and over 3 years of QA experience in a regulated environment. Join a science-driven culture that places quality as a strategic priority, not merely an administrative task.

Qualifications

• 3+ years of QA experience in a GMP/GxP-regulated environment.
• Strong working knowledge of SOP lifecycle management and regulatory expectations.
• Comfort working with digital systems and AI-assisted tools.

Responsibilities

• Own and maintain GMP/GxP SOPs, policies, and controlled documents across QA, QC, Manufacturing, and Clinical operations.
• Use PDAOAI to interrogate and cross-reference SOPs, deviations, CAPAs, and training records.
• Identify inconsistencies and gaps across the SOP corpus.

Skills

QA experience

Detail-oriented

Systems-thinking mindset

Strong documentation skills

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field

Tools

Veeva

MasterControl

TrackWise

Job description

A next-generation biotech organization in California is seeking a QA Specialist to support its GxP quality framework using innovative AI tools. This role offers unique responsibilities such as managing GMP/GxP SOPs and translating regulatory guidance into actionable procedures. The ideal candidate will have a Bachelor’s degree and over 3 years of QA experience in a regulated environment. Join a science-driven culture that places quality as a strategic priority, not merely an administrative task.