In-Process QA Specialist — Real-Time GMP Quality

Nivagenpharmaceuticals; 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 plan

Job summary

Nivagen Pharmaceuticals Inc. in Sacramento is seeking a Manufacturing QA Specialist to ensure pharmaceutical products meet quality standards during the manufacturing process, performing on-the-floor QA oversight, real-time testing, and documentation to ensure GMP compliance.

You will review batch records, support deviation investigations and CAPA, and collaborate with Manufacturing, Engineering, Validation, and Supply Chain teams to uphold a culture of quality and compliance on the production

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field or equivalent.
• 0–3 years of experience in sterile GMP manufacturing.
• Working knowledge of cGMP and FDA regulations (21 CFR).

Responsibilities

• Perform on-the-floor QA oversight in manufacturing areas with real-time quality support.
• Conduct line clearances, in-process checks, and verification activities.
• Review and approve GMP documentation including batch records and logs.
• Support deviation investigations, root cause analysis, and CAPA development.
• Assist with authoring and approval of QA procedures and Master Batch Records.
• Participate in GMP walkthroughs and inspection readiness activities.
• Support audits by preparing documentation and providing operational support.
• Collaborate with Manufacturing, Engineering, Validation, and Supply Chain teams.
• Assist with product disposition and quality review processes under supervision.

Skills

Root cause analysis

CAPA implementation

Quality testing equipment

GMP knowledge

FDA regulations

Cross-functional teamwork

Education

Bachelor’s degree in Life Sciences or related field

Tools

Compliance Wire

TrackWise

SAP

LIMS

eQMS platforms

Job description

Nivagen Pharmaceuticals Inc. in Sacramento is seeking a Manufacturing QA Specialist to ensure pharmaceutical products meet quality standards during the manufacturing process, performing on-the-floor QA oversight, real-time testing, and documentation to ensure GMP compliance.

You will review batch records, support deviation investigations and CAPA, and collaborate with Manufacturing, Engineering, Validation, and Supply Chain teams to uphold a culture of quality and compliance on the production