Lead Analyst, Quality Control

🚀 Lead Analyst, Quality Control

📍 Tustin, CA | On-site

🗓 Monday–Friday | 8:00 AM – 5:00 PM

🌱 Support the Quality and Release of Life-Saving Biopharmaceuticals

🎓 Ideal opportunity for experienced Quality Control professionals with strong analytical testing expertise in GMP biologics manufacturing environments

Are you passionate about quality control, analytical testing, and biologics manufacturing? We're looking for a Lead Analyst, Quality Control to join a growing Quality Control team supporting manufacturing, validation, process development, and stability studies in a GMP environment.

🔬 What You'll Do

✔ Lead and coordinate visual inspection activities supporting product lot release

✔ Execute assay qualification, method validation, special studies, investigations, and technology transfer projects

✔ Perform and review cell-based assays, ELISA, qPCR, immunoblot, electrophoresis, and other analytical testing activities

✔ Conduct aseptic sampling and routine laboratory testing including pH, conductivity, osmolality, and spectrophotometry

✔ Serve as a Subject Matter Expert for multiple testing methodologies and laboratory instruments

✔ Provide guidance and technical support to Junior Analysts and Analysts

✔ Review, revise, and author SOPs, test methods, study protocols, reports, and specifications

✔ Participate in regulatory inspections, continuous improvement initiatives, and cross-functional quality activities

✅ What We're Looking For

🎓 Bachelor's degree in Biology, Biochemistry, Chemistry, or an equivalent scientific field

🧪 Minimum 6 years of relevant hands-on experience working in a GMP environment

🧪 Experience with analytical testing and equipment, writing reports, procedures, specifications, GMPs, and regulatory audits

🧪 Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience

💰 Compensation

Hourly Rate: $46.15 - $57.69 per hour

✅ Additional compensation and benefits package available

📍 Please Note

✅ On-site in Tustin, CA

✅ Full-time Quality Control laboratory position

✅ Schedule is Monday through Friday, 8:00 AM to 5:00 PM

✅ Ability to work overtime and/or weekends when necessary

🚫 No relocation assistance mentioned

🚫 No visa sponsorship information provided

If this sounds like you, or someone in your network, I'd love to connect!

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