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QA Specialist, Phase I Manufacturing Los Angeles, CA 90041 $95,000 - $110,000 a year - Full-time Apply with Indeed Role Description We are hiring onsite QA staff to stand up quality operations for Phase I clinical manufacturing of a cell therapy product. Reporting to the Head of Quality, you will help the QA unit meet its responsibilities under 21 CFR Parts 210 and 211: controlling documentation, releasing materials, supporting batch disposition, and keeping the facility in a state of compliance. This is a hands-on role in a small, early-stage team, with direct visibility into how a clinical-stage quality system is built. Key Responsibilities Provide Quality Assurance oversight of clinical-stage cell therapy manufacturing operations to ensure compliance with applicable cGMP requirements, regulatory expectations, and internal quality standards. Review executed batch production records, manufacturing documentation, and associated quality control data for completeness, accuracy, traceability, and compliance with ALCOA+ data integrity principles. Support batch record review and product disposition activities, including evaluation of manufacturing records, QC results, deviations, and other quality documentation to support timely batch release decisions. Initiate, investigate, document, and support resolution of deviations, nonconformances, out-of-specification (OOS) results, and corrective and preventive actions (CAPAs), including root cause analysis and effectiveness verification. Author, review, revise, and maintain controlled quality documents, including standard operating procedures (SOPs), batch production records, forms, protocols, and quality system documentation. Support document control activities, including document issuance, revision management, approval workflows, archival, and maintenance of GMP records. Maintain and support GMP training programs, including training matrices, personnel qualification records, and verification of training compliance. Provide QA oversight of incoming raw materials, consumables, and manufacturing components, including review of Certificates of Analysis (CoAs), Certificates of Conformance (CoCs), Certificates of Origin (CoOs), material specifications, and associated documentation. Support material qualification, release, inventory status control, and traceability to ensure only approved materials are used in GMP manufacturing operations. Participate in supplier and contract service provider qualification, including vendor assessments, quality agreements, audits, and ongoing performance monitoring. Support facility and equipment qualification activities, including review of

IQ/OQ/PQ

documentation, calibration records, preventive maintenance, and equipment readiness for GMP operations. Review facility cleaning and environmental monitoring documentation, evaluate excursions, and support investigations and corrective actions to maintain manufacturing compliance. Participate in internal audits, quality assessments, inspection readiness activities, and implementation of continuous improvement initiatives. Support quality oversight of externally manufactured or tested materials and products, including review of contract manufacturing and laboratory testing documentation. Collaborate cross-functionally with Manufacturing, Quality Control, Process Development, Regulatory Affairs, and external partners to identify and resolve quality issues while maintaining clinical manufacturing timelines. Support implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including change controls, deviations, CAPAs, document control, and quality risk management. Contribute to the development and implementation of phase-appropriate quality systems and procedures to support the progression of clinical manufacturing operations, regulatory requirements and other duties as assigned.

Qualifications:

Bachelor's degree in a life science, engineering, or related field 2+ years of QA or QC experience in a GMP-regulated environment (pharma, biologics, or cell/gene therapy) Working knowledge of 21 CFR Parts 210/211, Good Documentation Practices, and data integrity (ALCOA+) Hands-on experience with at least one of: document control, batch record review, incoming material release, or facility/cleaning compliance Strong attention to detail and clear technical writing Ability to work onsite and support manufacturing schedules, including occasional off-hours

Preferred Experience or Qualifications:

Experience in cell therapy, iPSC, or aseptic processing environments Exposure to Phase I clinical manufacturing and phase-appropriate GMP Familiarity with

ICH Q7, Q9

(risk management), and Q10 (pharmaceutical quality system) Experience with electronic QMS or document management systems; awareness of 21 CFR Part 11 Experience supporting regulatory inspections or client/vendor audits Experience helping build a quality system at a start-up or newly commissioned facility Why Join Us As an early member of our team, you will have the opportunity to directly influence the development of innovative cell therapy technologies and help establish the quality foundation of a growing biotechnology company. Your work will play a critical role in advancing programs toward clinical milestones while collaborating with a team of scientists and innovators committed to making a meaningful impact for patients.

Compensation Note:

The annual base salary range for this role is $95,000 - 110,000. Individual pay decisions depend on various factors such as specific responsibilities, job requirements, and relevant experience and skills.

Benefits & Work Environment Health & Wellness:

Comprehensive Health, Dental, and Vision insurance programs.

Financial Security:

401(k) retirement plan options.

Work Location:

In-person / On-site at Cellio Lab facilities. Equal Opportunity Employer Cellio Therapeutics Inc. is an equal opportunity employer. We do not discriminate on the basis of race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable federal, state, or local laws.

Pay:

$95,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Education:

Bachelor's (Preferred)

Experience:

QA or QC :

2 years (Preferred) pharma, biologics, or cell/gene therapy: 2 years (Preferred) 1 CFR Parts 210/211: 1 year (Preferred)

Work Location:

In person