Specialist, Quality Assurance

Contractor/Consultant – Quality Assurance

Location:

Sacramento, CA

Engagement Type:
Contract / Consultant

Duration:
Approximately 6 months (July-December)

The Specialist, Quality Assurance (Contract) position is a key role in meeting the company’s quality policy through managing quality systems, including deviations, change control, CAPA, and document management. The candidate will make timely batch disposition decisions and support rapid processing of therapies.

• Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision for visual inspection tasks.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods; cosmetics, jewelry, and facial piercings are not permitted.

• May be required to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

Quality System Management

• Oversee quality systems including deviations, change controls, CAPAs, and document control.
• Investigate deviations thoroughly and timely, identify root causes, and implement corrective actions.
• Review and approve change controls for regulatory compliance.
• Maintain and improve CAPA processes for effective resolution of quality issues.

Batch Disposition

• Evaluate batch records and documentation to make informed release decisions.
• Collaborate with manufacturing and quality control teams to ensure products meet regulatory and quality standards.
• Monitor and document quality issues related to batch production and implement corrective measures.

Document Management

• Maintain the document management system with accurate, current, and compliant documents.
• Conduct regular reviews of quality documentation for adherence to protocols.

Regulatory Compliance

• Stay informed of current regulations, industry trends, and best practices.
• Assist in preparing for internal and external audits, ensuring audit-ready systems and documentation.

Training and Support

• Provide training and guidance to staff on quality systems, processes, and compliance requirements.
• Serve as a point of contact for quality-related inquiries and foster a culture of quality.

Continuous Improvement

• Participate in initiatives to enhance effectiveness and efficiency of quality systems.
• Identify areas for improvement and suggest solutions.
• Track completion of quality records and maintain metrics.
• Perform other duties as requested to support Quality.
• Collaborate with cross-functional teams to support overall quality of cell therapy products.

• Communicate effectively with team members and contribute to a positive collaborative environment.
• Actively participate in group and project teamwork and process improvements.
• Strong organizational skills and 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.
• Capable of wearing appropriate personal protective equipment.
• Willingness to work overtime and be available for on‑call support outside regular hours.

• Bachelor’s degree in a relevant scientific discipline with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree with 1+ year 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.
• Ability to meet project and testing timelines.
• Detail‑oriented with a commitment to data integrity and accuracy, and ability to identify data management problems.
• Ability to work collaboratively and respond to changing priorities and challenges.
• Experience with internal audits and document control management.

Salary: $35 – $50 per hour (based on prior experience, education, and location). Additional benefits include competitive medical, dental, and vision coverage, PTO, 401(k) plan, life and accidental death and disability coverage, parental leave, and subsidized daily lunches and snacks at on‑site locations.

We’re proud to be an equal‑opportunity employer, and we recognize that celebrating our differences creates stronger, lasting solutions that serve our team, our patients, and their healthcare providers.