Quality Assurance Consultant

Position: Quality Assurance Consultant at Orca Bio
Drive advancements in cell therapy with Orca Bio in Sacramento, CA as a Quality Assurance Consultant. This contract role focuses on quality system management and regulatory compliance.

Orca Bio is seeking a Quality Assurance Consultant for a six-month contract in its Sacramento facility. You will oversee quality systems including CAPAs, deviations, and documentation control. Candidates should have a strong background in GMP and be capable of ensuring compliance and quality in a biopharmaceutical environment.

Key Responsibilities:

• Manage quality systems, including deviations and change controls

• Evaluate batch records for informed release decisions

• Oversee document management for regulatory compliance

• Prepare for internal and external audits

• Provide quality training and support to staff

Requirements:

• Bachelor’s degree in a scientific field with 3+ years experience

• Strong knowledge of FDA regulations and GMP

• Experience in quality control in cell therapy is preferred

• Detail-oriented with data integrity focus

• Capable of working collaboratively in a regulated environment

Utilize your expertise in quality assurance to enhance the safety and efficacy of pioneering cell therapies.
#J-18808-Ljbffr