QA Specialist II — Biotech Quality & Batch Release

Regulatory Jobs

El Segundo (CA)

On-site

USD 93,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Bonus potential

Stock-based incentives

Paid time off

Benefits package

Medical/Dental/Vision/Life insurance

Job summary

Kite Pharma in Santa Monica, CA is seeking a QA professional focused on batch disposition and quality oversight in a GMP manufacturing setting. You will review batch records, deviations, CAPAs, and change controls while ensuring regulatory compliance and data integrity.

Ideal candidates have a life sciences background, 3–4 years in regulated environments, and strong collaboration across Quality, Manufacturing, and Supply Chain to support inspections and continuous improvement.

Qualifications

Bachelor's degree in life sciences or related field.
3–4 years in regulated pharma/biotech GMP environment.
Strong knowledge of cGMP, FDA, and quality systems.

Responsibilities

Review batch-related documentation and ensure issues are resolved for release.
Perform comprehensive quality review of batches for disposition.
Ensure process controls are followed in product manufacturing.
Manage deviations, investigations, and CAPAs; ensure timely closure.
Generate and update procedures and related forms.
Provide QA oversight for training, warehouse/inventory, and product introductions.