In Process QA Associate
$70,000–$80,000 year
On-site · Sacramento, California, United States
Job Summary
As an In Process QA Specialist, you will ensure pharmaceutical products meet quality standards during manufacturing by performing real-time monitoring, sampling, testing, and documentation. Responsibilities include conducting line clearances, reviewing GMP documentation, supporting deviation investigations, and collaborating with cross-functional teams. The role requires a Bachelor’s degree in a related field or equivalent experience, and 0-3 years in regulated manufacturing, strong organizational and communication skills, and working knowledge of cGMP.
Required Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience
- 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)
- Strong organizational skills and attention to detail
- Effective written and verbal communication skills
- Ability to work independently while collaborating within cross-functional teams
Desired Qualifications
- Basic knowledge of deviation management, CAPA, and change control processes preferred
- Familiarity with electronic systems such as ComplianceWire, TrackWise, SAP, LIMS, or similar eQMS platforms preferred
- Proficiency in Microsoft Office applications
Additional Requirements
- Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)
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