Quality Assurance Specialist I — GMP & Documentation

Orca Bio; Sacramento (CA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

Job summary

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.

Qualifications

• Bachelor’s degree in biology, biochemistry, immunology or related field with 1–3 years in quality control testing, analytical development, or GMP environments.
• Strong understanding of FDA regulations and GMP compliance.

Responsibilities

• Assist in managing quality systems such as deviations, change controls, CAPAs, and document control.
• Support investigations of deviations and document root cause analyses and corrective actions.
• Review and document change controls in compliance with regulatory requirements and internal procedures.
• Support batch records review and disposition during batch processing.

Skills

Quality Assurance

Education

Bachelor’s degree in a relevant scientific discipline

Tools

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.