On-Site In-Process QA Specialist (GMP)

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Pay range $70,000 - $80,000 per Year

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Job summary

A global pharmaceutical company located in Sacramento is seeking an In Process QA Specialist to ensure quality standards during manufacturing processes. Key responsibilities include real-time monitoring, testing, and documentation in line with Good Manufacturing Practices. The ideal candidate will have a Bachelor's degree in Life Sciences or related field and up to three years of relevant experience. The position fosters a culture of quality and continuous improvement, offering competitive pay and comprehensive benefits.

Qualifications

• 0–3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments.
• Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR).
• Basic knowledge of deviation management, CAPA, and change control processes preferred.

Responsibilities

• Perform routine on-the-floor QA oversight within manufacturing areas.
• Conduct line clearances, in-process checks, and verification activities.
• Review and approve GMP documentation including batch production records.
• Support deviation investigations and assist with CAPA development.
• Collaborate cross-functionally with Manufacturing, Engineering, and Validation teams.

Skills

Analytical skills

Problem-solving skills

Attention to detail

Communication skills

Education

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

Tools

Microsoft Office

ComplianceWire

TrackWise

SAP

LIMS

Job description

A global pharmaceutical company located in Sacramento is seeking an In Process QA Specialist to ensure quality standards during manufacturing processes. Key responsibilities include real-time monitoring, testing, and documentation in line with Good Manufacturing Practices. The ideal candidate will have a Bachelor's degree in Life Sciences or related field and up to three years of relevant experience. The position fosters a culture of quality and continuous improvement, offering competitive pay and comprehensive benefits.