In-Process QA Specialist — GMP & Quality Excellence

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

Benefits offered by this job

Pay range: $80,000-$90,000 per year

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a Manufacturing QA Specialist in Sacramento, CA.

The role ensures pharmaceutical products meet quality standards during manufacturing, with real-time monitoring, sampling, testing and strict adherence to GMP and regulatory requirements. The ideal candidate will perform on-the-floor QA activities, review batch records, support deviation investigations and CAPA, and collaborate with Manufacturing, Engineering, Validation and Supply Chain to drive continuous

Qualifications

• Bachelor's degree in Life Sciences or related field; 0–3 years in sterile GMP environments.
• Experience with GMP, FDA regulations (21 CFR) and cGMP.
• Strong analytical and problem-solving skills with CAPA experience.
• Detail-oriented with thorough documentation and record-keeping.

Responsibilities

• Provide real-time QA oversight on the manufacturing floor ensuring GMP compliance.
• Perform line clearances, in-process checks, and verifications during production.
• Review and approve GMP documentation including batch records and logs.
• Assist with deviation investigations, root-cause analyses, and CAPA development.

Skills

Root cause analysis

CAPA implementation

GMP knowledge

FDA regulations

Quality testing

Documentation

Cross-functional teamwork

MS Office

Attention to detail

Problem solving

Education

Bachelors in Life Sciences

Tools

Compliance Wire

TrackWise

SAP

LIMS

eQMS platforms

Job description

Nivagen Pharmaceuticals, Inc. is seeking a Manufacturing QA Specialist in Sacramento, CA.

The role ensures pharmaceutical products meet quality standards during manufacturing, with real-time monitoring, sampling, testing and strict adherence to GMP and regulatory requirements. The ideal candidate will perform on-the-floor QA activities, review batch records, support deviation investigations and CAPA, and collaborate with Manufacturing, Engineering, Validation and Supply Chain to drive continuous