Supervisor, Quality Assurance (Swing Shift)

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.

Key Responsibilities

Leadership and Team Management:

• 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.

Operational Support:

• 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.

Quality Systems & Compliance:

• Supervisors are expected to supervise Quality System performance for themselves and their team.
• 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.

Record Management Readiness:

• 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.

Continuous Improvement, Collaboration, and Communication:

• 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.

Minimum 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.