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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