Director, Analytical Development and Clinical Quality Control
Disc Medicine
Quality Assurance Technician
Orca
full-time
Posted on:
Location Type: Office
Location: Sacramento • California • 🇺🇸 United States
Visit company websiteSalary
💰 $23 - $29 per hour
Job Level
Mid-LevelSenior
About the role
- Provide on-the-floor QA oversight and real-time review of production records, equipment logbooks, and QC documentation to ensure cGMP compliance
- Partner with manufacturing and technical staff to review records and ensure product quality rationale supports batch disposition decisions
- Support real-time troubleshooting of equipment or production issues to minimize downtime and ensure uninterrupted manufacturing
- Conduct routine walkthroughs of classified areas (manufacturing and warehouse) to verify compliance with cGMP standards
- Escalate significant issues to QA and operational leadership as appropriate
- Provide coaching, training, and guidance to internal teams regarding compliance, documentation, and best practices
- Collaborate cross-functionally to address deviations and implement corrective and preventive actions (CAPA)
- Support broader QA functions as needed, including document control and deviation management
- Participate in continuous improvement efforts to enhance quality systems, efficiency, and compliance
- Work on-site Monday through Thursday from 1:00pm - 11:30pm on a 4x10 2nd shift schedule
Requirements
- Ability to work a consistent 2nd shift schedule (Monday–Thursday, 1:00pm - 11:30pm)
- Ability to wear cleanroom gowning and adhere to cleanroom entry and gowning requirements
- Demonstrated ability to identify and support resolution of technical issues
- Familiarity with cGMP regulations and documentation practices
- Proven experience collaborating in cross-functional or project teams
- Strong attention to detail and ability to follow QA processes and escalation pathways
- Coursework or experience in a scientific discipline (e.g., biology, microbiology, environmental science), including A.S. or B.S. degree (preferred)
- Prior experience in a regulated environment (e.g., GMP, biopharma, or cell therapy manufacturing) (preferred)
- Understanding of aseptic technique, environmental monitoring, and microbiology principles (preferred)
- Experience contributing to investigations, CAPAs, or other QA system elements (preferred)
- Strong organizational, communication, and problem-solving skills (preferred)
- Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks
- Must be able to meet cleanroom gowning requirements (no cosmetics, jewelry, facial piercings) and disclose any shedding skin conditions
- Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs
- May be required to work scheduled overtime, weekends, or holidays based on business needs
Benefits
- Eligible to receive pre-IPO equity
- Competitive medical, dental, and vision benefits
- Flexible PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Free daily lunches and snacks at on-site locations
- Shift-differential pay of +7%
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
cGMP compliancequality assurance processesdeviation managementCAPAaseptic techniqueenvironmental monitoringmicrobiology principlestroubleshootingdocument controlproduction record review
Soft skills
attention to detailcommunication skillsproblem-solving skillsorganizational skillscollaborationcoachingtrainingguidancecross-functional teamworkescalation pathways
