Specialist I, Quality Assurance

Orca Bio•Sacramento, CA

3d•$75,000 - $90,000•Hybrid

About The Position

The Specialist I, Quality Assurance is an integral entry-level role focused on supporting the effective implementation of our quality policies and systems. In this position, you will assist in the management and documentation of quality processes—including deviations, change controls, CAPAs, and document control—and contribute to batch disposition support to ensure products meet our stringent quality standards. Your work directly aids in maintaining regulatory compliance and enhancing our operational excellence, while also providing a foundation for professional growth within a dynamic, fast-paced environment.

Requirements

Bachelor’s degree in a relevant scientific discipline (e.g., biology, biochemistry, immunology) 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 consistently adhering to cGMP policies and procedures, including proper documentation and use of personal protective equipment.

Nice To Haves

Exposure to internal audit processes and document control is a plus.

Responsibilities

Assist in managing quality systems such as deviations, change controls, CAPAs, and document control.
Support thorough and timely investigations of deviations and assist in documenting root cause analyses and corrective actions.
Help review and document change controls in compliance with regulatory requirements and internal procedures.
Support the review of batch records and related documentation, assisting in the evaluation of batch release data.
Collaborate with manufacturing and quality control teams to document and address any quality issues during batch processing.
Assist in maintaining the document management system, ensuring accuracy and compliance with regulatory standards.
Help prepare quality documentation for internal and external audits and support adherence to cGMP protocols.
Provide basic training and support to staff on quality systems and procedures.
Collaborate with cross-functional teams, including manufacturing and research & development, to assist in quality improvement initiatives.
Participate in continuous improvement efforts and track the progress of quality-related activities.