QA Technician - cGMP Cell Therapy

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

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical insurance

Dental benefits

Vision benefits

PTO

401(k) plan

Life insurance

Disability coverage

Parental leave

Subsidized lunches

Job summary

Orca Bio Sacramento is seeking a Technician, Quality Assurance to support production of life-saving cell therapies. You will perform real-time QA oversight, review records, and collaborate with manufacturing, QC, and other QA functions to ensure compliance with cGMP standards.

Responsibilities include real-time documentation reviews, batch disposition support, equipment trouble-shooting, and CAPA-related activities, with emphasis on data integrity and meticulous record-keeping.

Qualifications

• Visual acuity 20/20 (corrected or uncorrected) to safely perform tasks such as visual inspection.
• Ability to meet cleanroom gowning requirements (full gowning, PPE) when needed.
• Experience in a regulated environment (GMP, biopharma, or cell therapy) preferred.
• Excellent attention to documentation and data integrity.

Responsibilities

• Perform real-time review of production records, equipment logbooks, and QC documentation to ensure compliance with cGMP and data integrity.
• Collaborate with manufacturing and technical staff to review records and support batch disposition decisions.
• Assist in real-time troubleshooting to minimize downtime and ensure uninterrupted manufacturing.
• Conduct routine walkthroughs of classified areas to verify cGMP compliance and safety.
• Escalate significant issues to QA and leadership as appropriate and participate in CAPA investigations.
• Provide coaching and training on compliance, documentation, and best practices to internal teams.
• Support document control and deviation management as part of QA functions.
• Contribute to continuous improvement of quality systems, processes, and efficiency.

Skills

Attention to detail

Documentation

Cross-functional collaboration

Communication

Problem-solving

Adaptability

Education

A.S. or B.S. degree

Job description

Orca Bio Sacramento is seeking a Technician, Quality Assurance to support production of life-saving cell therapies. You will perform real-time QA oversight, review records, and collaborate with manufacturing, QC, and other QA functions to ensure compliance with cGMP standards.

Responsibilities include real-time documentation reviews, batch disposition support, equipment trouble-shooting, and CAPA-related activities, with emphasis on data integrity and meticulous record-keeping.