Quality System Specialist

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

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.