Specialist, Quality Assurance - Day Shift

Orca Bio•Sacramento, CA

19h•$75,000 - $90,000•Onsite

About The Position

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process by developing next-generation cell therapies to provide significantly better survival rates with dramatically fewer risks for patients fighting blood cancer. Their purified, high-precision investigational cell therapies aim to replace patients' blood and immune systems with healthy ones and restore their lives. The company operates a dedicated clinical manufacturing facility in Sacramento, CA, which is crucial for producing high-precision cell therapy products and advancing their clinical pipeline. The Specialist, Quality Assurance position is a key role responsible for managing various quality systems, including production records, deviations, change control, corrective and preventive actions (CAPA), and document management. This role also involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by their product. This position offers a unique opportunity to make a difference in the lives of many patients.

Requirements

Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience
Understanding of FDA regulations, GMP compliance, and quality system processes
Able to meet project and testing timelines
Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management
Able to work collaboratively to respond to changing priorities and challenges
Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
Prior experience doing internal audits and document control management
Communicate effectively with team members and contribute to a positive and collaborative work environment
Actively participate in group and project teamwork; project and process improvements
Strong organizational skills and the ability to manage multiple tasks concurrently
Willingness to learn and adapt in a fast-paced, dynamic environment
Adhere to cGMP policies and procedures, including documentation activities
Able to wear appropriate personal protective equipment
Willingness to work overtime as required
Be available to provide on-call support outside regular business hours as needed

Nice To Haves

Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred

Responsibilities

Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.
Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.
Maintain and improve CAPA processes to ensure effective resolution of quality issues.
Evaluate batch records and associated documentation to make informed batch release decisions.
Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
Monitor and document any quality issues related to batch production and implement corrective measures as necessary.
Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.
Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.
Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.
Provide training and guidance to staff on quality systems, processes, and compliance requirements.
Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.
Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
Identify areas for improvement within quality operations and suggest appropriate solutions.
Track completion of quality records and maintain metrics.
Perform other duties as requested by supervisor/manager to support Quality
Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.