Biotech QA Supervisor - Manufacturing & Compliance

Orca Bio; Sacramento (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Shift differential +5%

Medical, dental, and vision benefits

PTO

401(k)

Job summary

Orca Bio, based in Sacramento, CA, seeks a Supervisor, Quality Assurance to lead the QA team supporting manufacturing and QC while upholding cGMP, FDA, and ICH standards.

The role requires a Bachelor’s degree in Life Sciences and 5+ years QA experience, including 1–2 years in leadership, with strong analytical and communication skills. Swing shift and competitive benefits are offered.

Qualifications

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

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.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Analytical skills

Communication

Organizational skills

Problem solving

Education

Bachelor’s degree in Life Sciences/Chemistry/Biology

Tools

Documentation systems

Job description

Orca Bio, based in Sacramento, CA, seeks a Supervisor, Quality Assurance to lead the QA team supporting manufacturing and QC while upholding cGMP, FDA, and ICH standards.

The role requires a Bachelor’s degree in Life Sciences and 5+ years QA experience, including 1–2 years in leadership, with strong analytical and communication skills. Swing shift and competitive benefits are offered.