Quality Assurance Specialist I — GMP & Documentation

Orca Bio; Sacramento (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Orca Bio in Sacramento is seeking a Specialist I, Quality Assurance to support the implementation of quality policies and systems. You will assist with deviations, change controls, CAPAs, and document control to ensure batch disposition meets stringent quality standards and regulatory expectations.

You will collaborate with cross-functional teams to maintain data integrity, accurate documentation, and clear communication throughout the quality system.

Qualifications

• Bachelor's degree in a scientific discipline.
• 1–3 years of experience in GMP/regulatory environments.
• Strong data integrity, documentation, and communication skills.

Responsibilities

• Support implementation of quality policies and systems.
• Assist deviations, change controls, CAPAs, and document control.
• Contribute to batch disposition to ensure products meet quality standards.

Skills

Data integrity

Documentation

Communication

Education

Bachelor's degree in a scientific discipline

Job description

Orca Bio in Sacramento seeks a Specialist I, Quality Assurance to support the implementation of quality policies and systems. You will assist in deviations, change controls, CAPAs, and document control, contributing to batch disposition to ensure products meet stringent quality standards.

Qualifications include a bachelor's degree in a scientific discipline and 1-3 years in GMP/regulatory environments, with strong data integrity, documentation, and communication skills.