Supervisor, Quality Control

Orcabiosystems; Sacramento (CA); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Subsidized daily lunches and snacks

401(k) plan

Pre-IPO equity and annual bonus

Job summary

Orcabiosystems in Sacramento is seeking a Supervisor for Quality Control (QC) to oversee the laboratory operations. This role involves ensuring compliance with regulatory standards, conducting audits, and leading a team to maintain data integrity.

The ideal candidate will possess a Bachelor’s degree in a scientific discipline and have at least 5 years of experience in a GMP-regulated environment. Opportunities for career advancement and excellent benefits are provided.

Qualifications

• Minimum 5 years of experience in a GMP-regulated QC laboratory.
• At least 2 years in a supervisory or lead role.
• Strong organizational and analytical skills.

Responsibilities

• Oversee daily operations within the QC laboratory.
• Ensure compliance with regulatory standards.
• Conduct audit trail reviews and lead investigations.
• Supervise and support a team of QC analysts.

Skills

Knowledge of cGMP

Leadership

Analytical skills

Communication skills

Education

Bachelor’s degree in Chemistry, Biology, or related field

Job description

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) oversees 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.

Schedule

• 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

Responsibilities

• 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, jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• 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. They may also be required to work scheduled overtime, weekends, or holidays based on business needs.
• 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.
• 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 Quality and keep the lab current with industry regulations, standards, and best practices related to quality control.

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.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job‑related factors as permitted by law. For remote‑based positions, this range may vary based on your local market. 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.

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