QA Supervisor — Biotech Manufacturing & Compliance

Orcabiosystems; Sacramento (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Parental leave

Subsidized daily lunches

Job summary

Orca Bio in Sacramento seeks a QA Supervisor to oversee day-to-day QA activities supporting manufacturing and QC operations, ensuring cGMP compliance and robust documentation. You will lead a team, provide training, and partner with cross-functional teams to resolve issues in real time.

This swing shift role (Mon-Fri, 2:00pm–10:30pm) offers competitive compensation, pre-IPO equity, annual bonus, and comprehensive benefits at our 100,000-square-foot facility near Metro Air Pkwy.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, or related discipline.
• Minimum of 5 years of QA experience in regulated pharma/biotech/medical devices.
• Minimum of 1–2 years in a leadership or supervisory role preferred.
• Strong knowledge of cGMP, FDA, and ICH guidelines.
• Excellent written and verbal communication; detail-oriented.

Responsibilities

• Supervise, mentor, and develop QA technicians assigned to manufacturing and QC.
• Schedule daily QA activities to ensure timely support for production and lab functions.
• Provide ongoing training, performance evaluations, and career development support.
• Serve as QA representative in cross-functional meetings, promoting a culture of compliance and continuous improvement.
• Provide technical guidance 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).
• Support real-time issue resolution during production and testing activities, escalating as needed.
• Monitor compliance with cGMP, GDP, and internal SOPs.
• Assist in the preparation and review of master batch records, SOPs, and other documentation.
• 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 to drive resolution of quality and technical issues.
• Identify opportunities to enhance operations, workflow efficiency, and compliance practices.

Skills

Leadership

Quality Assurance

Communication

Analytical thinking

Detail orientation

Education

Bachelor’s degree in Life Sciences, Chemistry, Biology, or related discipline

Job description

Orca Bio in Sacramento seeks a QA Supervisor to oversee day-to-day QA activities supporting manufacturing and QC operations, ensuring cGMP compliance and robust documentation. You will lead a team, provide training, and partner with cross-functional teams to resolve issues in real time.

This swing shift role (Mon-Fri, 2:00pm–10:30pm) offers competitive compensation, pre-IPO equity, annual bonus, and comprehensive benefits at our 100,000-square-foot facility near Metro Air Pkwy.