Quality System Specialist

BioTalent; Tustin (CA); On-site; USD 58,000 - 74,000; Full time

Benefits offered by this job

Health, Dental, Vision Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent in Tustin, CA is seeking a Senior Specialist, Quality Systems to join a biopharmaceutical team supporting life-saving biologics. This role focuses on deviation investigations, CAPA handling, GMP compliance, and meticulous documentation.

You will review and approve deviation reports, support CAPA activities, prepare SOPs and controlled documents, and ensure inspection readiness through cross-functional collaboration and continuous improvement initiatives.

Qualifications

• 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 with Quality Systems, OOS Investigations, Quality Documentation, Quality Management Systems (QMS).

Responsibilities

• 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.

Skills

Quality Systems

CAPA investigations

Deviations

GMP compliance

Documentation

Inspection readiness

Education

B.A. or B.S. degree

Job description

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
• OOS Investigations
• Quality Documentation
• Quality Management Systems (QMS)

Bonus

• Experience with biologics preferred
• Experience using Quality Management Systems and electronic document management systems
• Strong technical writing and editing skills

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

• Health, Dental, and Vision Insurance
• 401(k) Matching
• Paid Time Off

Please Note

• On-site in Tustin, CA
• Overtime and weekend availability may be required
• 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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