Supervisor, Quality Assurance (Swing Shift)

Orca Bio•Sacramento, CA

10d•Onsite

About The Position

Orca Bio is a commercial-stage biotechnology company focused on developing next-generation cell therapies to improve survival rates and reduce risks associated with stem cell transplants. The Supervisor, Quality Assurance is responsible for overseeing the daily activities of the QA team that supports manufacturing and quality control operations. This role ensures compliance with regulatory standards, internal procedures, and quality expectations, while providing leadership and guidance to foster continuous improvement, compliance, and operational excellence. The department reviews production records, equipment logbooks, and QC documentation in real-time and collaborates across the site to support manufacturing, issue resolution, and documentation.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related scientific discipline
Minimum of 5 years of experience in Quality Assurance within a regulated pharmaceutical, biotechnology, or medical device environment.
Strong knowledge of cGMP, FDA, and ICH guidelines.
Strong analytical, problem-solving, and decision-making skills.
Excellent written and verbal communication.
Detail-oriented with strong organizational skills.
Ability to manage multiple priorities and work in a fast-paced environment.
Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision.
Must be able to meet cleanroom gowning requirements, including wearing full gowning for extended periods.
Ability to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.

Nice To Haves

Minimum of 1-2 years in a leadership or supervisory role is preferred.

Responsibilities

Supervise, mentor, and develop a team of QA technicians assigned to manufacturing and QC operations.
Schedule and prioritize daily QA activities to ensure timely support for production and lab functions.
Provide ongoing training, performance evaluations, and career development support for team members.
Serve as QA representative in cross-functional meetings related to operations and quality systems, promoting a culture of compliance and continuous improvement.
Provide technical guidance and mentorship to ensure high quality and compliant practices.
Oversee on-the-floor QA support for manufacturing and QC activities including batch record review, in-process checks, line clearance, and deviation response.
Ensure timely review and approval of manufacturing and QC documentation (e.g., batch records, logbooks, equipment use records, test data).
Support real-time issue resolution during production and testing activities, escalating concerns as needed.
Monitor compliance with Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal SOPs.
Assist in the preparation and review of master batch records, standard operating procedures (SOPs), and other relevant documentation.
Ensure effective implementation and adherence to quality systems including deviation management, CAPAs, change control, and investigations.
Review and approve deviations, investigations, and change controls related to manufacturing and QC.
Participate in internal audits, regulatory inspections, and third-party audits as required.
Support trending of quality data and contribute to continuous improvement initiatives.
Collaborate with cross-functional teams (QC, Manufacturing, MSAT, etc.) to drive resolution of quality and technical issues.
Monitor record management conditions and practices to ensure consistent compliance with cGMP and FDA/EMA regulations.
Manage documentation, equipment logs, and records to support readiness for internal and external inspections.
Lead preparation activities for audits and regulatory inspections, including document reviews and mock audits.
Identify opportunities to enhance operations, workflow efficiency, and compliance practices.
Participate in the revision and development of SOPs and policies.
Liaise with Manufacturing, QC, Validation, Engineering, and other departments to ensure QA oversight and alignment.
Communicate quality expectations, regulatory changes, and quality system updates to the team and relevant stakeholders.
Support implementation of new procedures, processes, and equipment from a QA perspective.
Perform other duties as requested by supervisor/manager to support Quality.
Stay current with industry regulations, standards, and best practices related to quality assurance.