Posted 3 months ago

Supervisor, Quality Control

SacramentoOn-siteFull-time

AI Summary

Supervisor overseeing QC laboratory operations, ensuring compliance, conducting audit trail reviews, leading investigations of OOS results and deviations, and guiding a QC team to maintain inspection readiness.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness.

We are multiple positions across the following schedules:

Day Shift:

• 6:00am to 6:30pm or

• 6:30am to 7:00pm

Night Shift:

• 6:00pm to 6:30am or

• 6:30pm to 7:00am

Work Week Schedule:

• Sunday, Monday, Tuesday + every other Wednesday or

• Thursday, Friday, Saturday + every other Wednesday

Physical Demands

Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.

Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key Responsibilities

Lab work and supervisor roles: Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products. Supervise the QC team, supporting data verification, leading investigations, prioritizing tasks, and collaborating with other teams. Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies.

Data Integrity and Audit Trail Review: Ensure GMP compliance by conducting audit trail reviews, identifying data integrity issues, and ensuring proper documentation. Lead and document QC testing results, and assist with preparing and reviewing batch records, SOPs, and related documentation to ensure adherence to cGMP regulations.

Investigations and CAPA: Oversee Quality System investigations into OOS results, atypical findings, and lab deviations. Ensure root cause analysis, documentation, and implementation of CAPAs, collaborating with cross-functional teams to resolve quality issues.

Lab Inspection Readiness: Monitor lab conditions to ensure compliance with cGMP and FDA/EMA regulations, maintaining documentation, equipment logs, and records for inspection readiness. Lead preparation activities for internal and external audits, including document reviews and mock audits.

Team Leadership and Oversight: Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high-quality, compliant practices.

Documentation and Reporting: Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews.

Identify opportunities to improve lab operations, workflow efficiency, and compliance practices, and actively participate in revising and developing SOPs and policies.

Collaborate with cross-functional teams to ensure that external requests and activities align with site priorities.

Perform other duties as requested by supervisor/manager to support QualityStay current with industry regulations, standards, and best practices related to quality control.

Stay current with industry regulations, standards, and best practices related to quality control.

Minimum Qualifications

Bachelor’s degree in Chemistry, Biology, or a related scientific discipline (Master’s degree preferred).

Minimum of 5 years of experience in a GMP-regulated QC laboratory, with at least 2 years in a supervisory or lead role.

Strong knowledge of cGMP, FDA, and ICH guidelines.

Proven experience conducting audit trail reviews and leading laboratory investigations.

Excellent organizational, analytical, and communication skills.

Ability to manage multiple priorities and work in a fast-paced environment.

Skills

Analytical TestingAssay Transfer/validationAudit Trail ReviewsBatch RecordsCAPACGMPCross-Functional CollaborationData IntegrityDocumentation And ReportingFDAGMPICH GuidelinesLaboratory InvestigationsLeadershipMentorshipOOS InvestigationsQuality ControlQuality System ManagementSOPsTraining