Real-Time In-Process QA Specialist

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Annual bonus

Job summary

Nivagen Pharmaceuticals Inc. is seeking an In Process QA Specialist in Sacramento, CA.

This role ensures products meet quality standards during manufacturing, performing real‑time monitoring, sampling, testing, and documentation to uphold GMP and FDA requirements. Responsibilities include on-the-floor QA oversight, line clearances, document review, deviation investigations, and cross‑functional collaboration to drive quality and continuous improvement.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field required.
• 0–3 years of sterile GMP manufacturing experience preferred.
• Strong analytical and problem-solving skills with CAPA experience.

Responsibilities

• Perform on-the-floor QA oversight in manufacturing areas.
• Conduct line clearances and in-process checks during operations.
• Review and approve GMP documentation including batch records.
• Support deviation investigations and CAPA development.
• Assist with QA procedures, controlled documents, and master records.

Education

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

Tools

Compliance Wire

TrackWise

SAP

LIMS

eQMS platforms

Job description

Nivagen Pharmaceuticals Inc. is seeking an In Process QA Specialist in Sacramento, CA.

This role ensures products meet quality standards during manufacturing, performing real‑time monitoring, sampling, testing, and documentation to uphold GMP and FDA requirements. Responsibilities include on-the-floor QA oversight, line clearances, document review, deviation investigations, and cross‑functional collaboration to drive quality and continuous improvement.