Biotech QA Specialist I — Quality Impact

Orca-Bio; California (MO); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Pre-IPO equity

Medical, dental, vision benefits

PTO and 401(k)

Life and accidental death & disability

Parental leave

Lunches on-site

Job summary

Orca Bio is seeking a Specialist I, Quality Assurance to support the implementation of quality policies and systems at our Sacramento site. You will assist with deviations, change controls, CAPAs, and document control, and contribute to batch disposition activities to ensure products meet our quality standards.

The role provides a foundation for professional growth in a fast-paced GMP environment, with opportunities to collaborate across manufacturing and quality control teams.

Qualifications

• 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.
• Strong organizational skills, attention to detail, and a commitment to data integrity.
• Excellent communication skills and the ability to work independently and as part of a team in a fast-paced, regulated environment.

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, assisting in the evaluation of batch release data.
• Document Management & Regulatory Support: Assist in maintaining the document management system, ensuring accuracy and compliance with regulatory standards.
• Training, Collaboration, and Continuous Improvement: Provide basic training and support to staff on quality systems and procedures and work with cross-functional teams to drive quality improvements.

Skills

Attention to detail

Organizational skills

Communication skills

Teamwork

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 at our Sacramento site. You will assist with deviations, change controls, CAPAs, and document control, and contribute to batch disposition activities to ensure products meet our quality standards.

The role provides a foundation for professional growth in a fast-paced GMP environment, with opportunities to collaborate across manufacturing and quality control teams.