QA Specialist I: Quality Systems & Compliance

Logoslabs; San Francisco (CA); On-site; USD 60,000 - 75,000; Full time

Job summary

Orca Bio is seeking 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 standards.

This entry-level role provides regulatory and GMP exposure in a fast-paced environment, offering professional growth within a growing biopharma company and an opportunity to help advance life-saving therapies.

Qualifications

• Bachelor's degree in a relevant scientific discipline with 1–3 years of related experience in quality control testing, analytical development, or GMP environments.
• Basic understanding of FDA regulations, GMP compliance, and quality system processes.
• Strong organizational skills, attention to detail, and a commitment to data integrity.
• Excellent communication skills and the ability to work both independently and as part of a team in a fast-paced, regulated environment.
• Willingness to learn, adapt, and work overtime as necessary, while adhering to cGMP policies and procedures.

Responsibilities

• Quality System Support: Assist in managing quality systems such as deviations, change controls, CAPAs, and document control.
• Batch Disposition Support: Support the review of batch records and related documentation and assist in evaluation of batch release data.
• Document Management & Regulatory Support: Maintain the document management system and prepare quality documentation for audits.
• Training, Collaboration, and Continuous Improvement: Provide basic training and collaborate with cross-functional teams to drive quality initiatives.

Education

Bachelor's degree in a relevant scientific discipline

Job description

Orca Bio is seeking 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 standards.

This entry-level role provides regulatory and GMP exposure in a fast-paced environment, offering professional growth within a growing biopharma company and an opportunity to help advance life-saving therapies.