Quality System Specialist

🚀 Senior Specialist, Quality Systems

📍 Tustin, CA | 🕒 Full-Time |

🗓 Monday–Friday

🌱 Help Ensure Quality in Life-Saving Biopharmaceuticals

Are you passionate about Quality Systems, CAPAs, deviations, GMP compliance, and documentation excellence? We’re looking for a Senior Specialist, Quality Systems to join a growing biopharmaceutical team supporting innovative biologic therapies.

If you thrive in a fast-paced quality environment and enjoy working with deviation investigations, CAPAs, quality documentation, and inspection readiness, this could be your next opportunity.

🔬 What You'll Do

✔ Review, edit, and approve deviation reports, calibration exceptions, OOS, and OOL investigations

✔ Support CAPA authoring, review, and approval activities

✔ Prepare and review SOPs, forms, batch production records, and controlled documents

✔ Participate in the generation and revision of quality systems and project documentation

✔ Support development, validation, and stability documentation activities

✔ Collaborate with cross-functional teams to resolve quality system issues and discrepancies

✔ Represent Quality on multidisciplinary project teams

✔ Provide support to internal and external customers on Quality topics

✔ Maintain inspection readiness and support audit preparation activities

✔ Support continuous improvement initiatives and Quality Management System activities

✅ What We're Looking For

🎓 B.A. or B.S. degree (preferably in a Life Sciences field)

🧪 Minimum 4–5 years of experience in the biopharmaceutical industry (preferably with biologics)

🧫 Hands-on experience or exposure with:

• Quality Systems

• CAPA Management

• Deviations

• OOS Investigations

• OOL Investigations

• GMP Compliance

• Quality Documentation

• SOP Development

• Batch Production Records (BPRs)

• Root Cause Analysis

• Impact Assessments

• Inspection Readiness

• Controlled Documents

• Quality Management Systems (QMS)

• Technical Writing

• Document Management Systems

Bonus

• Experience with biologics preferred

• Experience using Quality Management Systems and electronic document management systems

• Strong technical writing and editing skills

💰 Compensation Range

$42.69 – $53.36 per hour (depending on experience and qualifications)

Comprehensive Benefits

Health, Dental, and Vision Insurance

401(k) Matching

Paid Time Off

Career Growth Opportunities

📍 Please Note

✅ On-site in Tustin, CA

🕒 Full-time Monday–Friday, 8:00 AM–5:00 PM schedule

✅ Overtime and weekend availability may be required

🚫 No relocation assistance

🚫 No visa sponsorship available

🇺🇸 Applicants must already be authorized to work in the U.S.

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

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