Technician, Quality Assurance – Night Shift
Role Overview
This position ensures the quality and compliance of cell therapy manufacturing through real-time oversight and documentation review. Working overnight hours, the technician supports continuous production by verifying adherence to cGMP standards, reviewing batch records, and contributing to batch release decisions. The role operates within a highly regulated cleanroom environment and requires close coordination with manufacturing and technical teams.Key Responsibilities
- Conduct immediate review of production records, equipment logs, and quality control documentation to confirm compliance with cGMP and proper documentation practices
- Collaborate with manufacturing personnel to assess product quality and support final batch disposition determinations
- Assist in resolving real-time production or equipment issues to maintain manufacturing continuity
- Perform regular inspections of controlled environments, including manufacturing zones and storage areas, to verify compliance
- Identify and escalate critical quality concerns to appropriate leadership
- Provide guidance and training to staff on documentation standards, compliance protocols, and quality best practices
- Support deviation investigations and the implementation of corrective and preventive actions (CAPA)
- Contribute to document control, deviation tracking, and other quality system functions as needed
- Engage in initiatives to improve quality processes, system efficiency, and regulatory compliance
Qualifications
Candidates must be able to comply with strict cleanroom protocols, including full gowning with face coverings, gloves, hoods, and goggles for extended durations. Visual acuity of 20/20 (corrected or uncorrected) and normal color vision are required. Individuals must disclose any skin conditions that may cause particulate shedding. The use of makeup, nail polish, jewelry, or facial piercings is prohibited in cleanroom areas.
Essential qualifications include experience in identifying and helping resolve technical issues, familiarity with cGMP standards, strong attention to detail, and the ability to follow defined QA procedures and escalation paths. Experience working in cross-functional teams is necessary.
Preferred Background
- Academic coursework or degree in a scientific field such as biology, microbiology, or environmental science
- Experience in a regulated manufacturing setting, particularly in biopharmaceuticals, GMP, or cell therapy
- Knowledge of aseptic techniques, environmental monitoring, and microbiological principles
- Proven organizational, communication, and problem-solving abilities
- Ability to adjust to changing priorities in a fast-moving production environment
- Experience participating in investigations, CAPA processes, or quality system activities
Work Schedule & Location
This is an onsite role based at one of two Sacramento facilities. The standard night shift runs from 6:00 PM to 6:30 AM or 6:30 PM to 7:00 AM. Workweek consists of Sunday, Monday, Tuesday, and every other Wednesday, or an alternate pattern of Thursday, Friday, Saturday, and every other Wednesday. Scheduled overtime, weekend, or holiday work may be required based on operational demands.
Environment & Culture
The workplace emphasizes precision, data integrity, and meticulous documentation. Team members are expected to be proactive, reliable, and committed to quality. A collaborative approach and strong communication skills are essential. The organization values adaptability and dedication to its mission of advancing patient care through innovative therapies.
