Senior Quality Systems Specialist – Biopharma

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

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.