Senior Quality Systems Specialist – Biopharma & CAPA

BioTalent; Tustin (CA); On-site; USD 59,000 - 73,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent in California is seeking a Senior Specialist, Quality Systems to support life-saving biopharmaceutical programs. You will review deviation reports, assist CAPA processes, and help maintain GMP documentation and inspection readiness.

The role requires 4–5 years in biopharma, preferably with biologics, and hands-on experience with QMS, OOS investigations, and quality systems. On-site in Tustin, CA, with competitive hourly compensation and benefits.

Qualifications

• B.A. or B.S. degree (Life Sciences) required.
• 4–5 years of experience in biopharmaceutical industry (biologics preferred).
• Hands-on experience with Quality Systems, OOS investigations, quality documentation, and 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

OOS Investigations

CAPA

Quality Documentation

QMS

Education

Bachelor's degree in Life Sciences

Tools

EDMS

Job description

BioTalent in California is seeking a Senior Specialist, Quality Systems to support life-saving biopharmaceutical programs. You will review deviation reports, assist CAPA processes, and help maintain GMP documentation and inspection readiness.

The role requires 4–5 years in biopharma, preferably with biologics, and hands-on experience with QMS, OOS investigations, and quality systems. On-site in Tustin, CA, with competitive hourly compensation and benefits.