What are the responsibilities and job description for the Quality Compliance Engineer position at Astrix?
Pay Rate Low: 90000 | Pay Rate High: 120000
Our client is a global, publicly traded bioscience leader dedicated to advancing human health-span and healthy aging through strategic, world-class research collaborations.
Title: Quality Compliance Engineer
Location: Hybrid – Tustin, CA
Schedule: M-F, 8-5pm. This is a hybrid position. 3 days onsite is a must.
Salary: $90K–$120K flexibility for strong candidates
Direct Hire
We are seeking a Quality Engineer to support quality operations, process improvements, and regulatory compliance in a fast-paced environment. This role will partner cross-functionally to ensure products meet the highest standards for safety, quality, and compliance.
Key Responsibilities
Our client is a global, publicly traded bioscience leader dedicated to advancing human health-span and healthy aging through strategic, world-class research collaborations.
Title: Quality Compliance Engineer
Location: Hybrid – Tustin, CA
Schedule: M-F, 8-5pm. This is a hybrid position. 3 days onsite is a must.
Salary: $90K–$120K flexibility for strong candidates
Direct Hire
We are seeking a Quality Engineer to support quality operations, process improvements, and regulatory compliance in a fast-paced environment. This role will partner cross-functionally to ensure products meet the highest standards for safety, quality, and compliance.
Key Responsibilities
- Lead investigations into manufacturing deviations, nonconformances, and process defects, including root cause analysis and CAPA implementation
- Drive continuous improvement initiatives using quality metrics, data analysis, and operational KPIs
- Support SOP development and process optimization initiatives
- Conduct risk assessments (FMEA), supplier qualifications, and co-manufacturer audits
- Manage product specifications, third-party certifications (NSF, Halal, Kosher), and recall/mock recall activities
- Perform quality assessments for new formulas/products to ensure regulatory compliance
- Collaborate closely with internal teams, external partners, and suppliers
- BS degree in Biology, Chemical Engineering, or related scientific field
- 3 years of Quality Engineering/QA experience within pharmaceuticals, CDMO, medical device, food, cosmetics, or dietary supplements
- Strong GMP/GDP knowledge and experience with FDA regulations (21 CFR 111, 117, 210, 211) and Quality Systems
- Hands-on experience with investigations, deviations, CAPAs, supplier qualification, and auditing
- Data-driven mindset with experience using metrics and statistical methods/Six Sigma tools
- Strong communication and cross-functional collaboration skills
- Ability to travel up to 25% domestically with occasional international travel
- Pharmaceutical industry experience strongly preferred (in-house or CDMO environment)
- Experience in fast-paced manufacturing or regulated environments
- Must be authorized to work in the US.
Salary : $90,000 - $120,000