Specialist, Quality Assurance (Contract Role)

About the role

The Specialist, Quality Assurance (Contract) position at Orca Bio is a key role in ensuring the quality of our investigational cell therapy products. This role is crucial in managing the quality systems, including deviations, change controls, CAPAs, and document control, while also evaluating batch records and associated documentation to make informed batch release decisions.

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.
• Aid 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.

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.
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.
• 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.
• Able to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment.
• Experienced in performing internal audits and document control management.

Qualifications

• Communicate effectively with team members and contribute to a positive and collaborative work environment.
• Able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Willingness to work overtime as required.
• Be available to provide on-call support outside regular business hours as needed.
• Willingness to work remotely.

Skills

• Strong organizational skills and the ability to manage multiple tasks concurrently.
• Ability to work independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment.
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment.
• Detail-oriented with a commitment to data integrity and accuracy.
• Ability to identify problems with data management.
• Experience in performing internal audits and document control management.

Benefits

Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Pay

$35 - $50 an hour

Schedule

Approximately 6 months (July-December)