Quality Control Analyst

Quality Control Analyst

Location : On-site — Irvine, California
Department: Quality
Employment Type: Full-time, Non-Exempt

About AIVITA Biomedical

AIVITA Biomedical is a fast-growing biotechnology company advancing personalized vaccines for the prevention of infectious disease and treatment of cancer. Our autologous cell therapy platform, built on cutting-edge immunology and stem cell science, is driving multiple clinical programs and innovative vaccine technologies. We operate in a dynamic, collaborative environment where every team member directly contributes to product quality, patient safety, and our mission to transform lives through science.

About the Role

The Quality team is hiring a Quality Control Analyst to support analytical testing and product release across our clinical, R&D, and cosmetic programs. This is a hands-on, execution-focused role for someone with two to three years of relevant experience who wants to build depth in cGMP quality control and grow with the company over time.

You will run established analytical methods, generate the documentation that supports product release, and initiate the quality records that keep our system inspection-ready. The role offers broad exposure across multiple product types in a small-company setting, with mentorship from Quality Assurance leadership and a clear path to expand your assay capability over time. This role also flexes into document control, materials management, and other quality operations during lower-volume periods, and provides opportunity to strengthen experience across multiple quality functions. The position reports to the Manager, Quality Assurance.

What You'll Do

Analytical Testing and Product Release

• Execute established analytical test methods supporting release of intermediate and final products across clinical, R&D, and cosmetic programs.
• Perform analytical assays including immunocytochemistry, flow cytometry, PCR, ELISA, ELISpot, endotoxin, sterility, Gram stain, and cell counts by Coulter Counter, Cellometer, and dye exclusion microscopy.
• Ensure accurate receipt, identification, and documentation of samples submitted for analysis.
• Complete, report, and generate certificates of analysis and specifications to support on-schedule product release.
• Prepare and submit samples to contract laboratories for outsourced testing and coordinate receipt of results.

Documentation and Quality

• Maintain complete, contemporaneous, and legible records in accordance with good documentation practices and quality SOPs.
• Initiate and draft laboratory investigation and quality event documentation, including deviations, out-of-specification results, non-conforming material reports, and CAPA records, for Quality Assurance review.
• Draft technical study protocols, reports, and operational SOPs for review and approval.
• Compile and evaluate test data in support of stability studies and process development activities.

Troubleshooting and Laboratory Support

• Provide first-line troubleshooting of routine assay performance and document findings for follow-up.
• Recognize atypical or out-of-specification results and escalate promptly through appropriate channels.
• Maintain QC laboratory space, organization, and reagent and consumable stock levels.

Teamwork and Flexibility

• Collaborate closely with Manufacturing, QA, R&D, and project management to meet clinical and operational timelines.
• Provide cross-functional quality support, including document control, issuance and archiving; material receipt, inspection and inventory management; and other duties as assigned.
• Support internal and external audits, including record retrieval and evidence compilation.
• Work primarily standard weekday hours, with flexibility for occasional early mornings, evenings, or weekends driven by manufacturing and release schedules.

Who You Are

Required Qualifications

• Bachelor's degree in biology, biochemistry, biotechnology, biomedical science, or a closely related life-science field.
• Minimum of two years, and ideally three years, of hands-on experience in quality control, analytical testing, or a comparable regulated laboratory environment.
• Experience working within cGMP or similar regulated environments, including completing controlled documentation.
• Working proficiency in cell counting by manual and automated methods, and hands-on experience with at least one of flow cytometry, ELISA, or PCR.
• Proven aseptic technique and the ability to qualify for gowning and work in classified cleanroom space.
• Strong good documentation practices habits, including accurate, real-time record keeping and correct error correction.
• Strong attention to detail, organization, and follow-through across concurrent assays and their documentation.
• Self-starter who identifies opportunities and volunteers for it, rather than waiting to be assigned the next task.
• Demonstrated ability to learn new protocols quickly and execute them consistently after training.
• Comfortable working with limited day-to-day oversight, exercising sound judgment on routine matters and escalating appropriately. Clear, professional written and verbal communication skills.
• Willingness to work an on-site role with occasional schedule flexibility based on program needs.

Preferred Qualifications

• Experience in clinical-stage cell therapy, biologics, or other human cell-based product manufacturing.
• Exposure to analytical method qualification or validation activities in a supporting capacity.
• Experience issuing or reviewing certificates of analysis or release documentation.
• Experience with root cause investigations, risk analysis, and technical writing.
• Familiarity with ICH guidelines and ISO 9001.
• Prior participation in an FDA, registrar, or client audit.
• Experience handling human clinical specimens such as tumor tissue or blood-derived products.

What Success Looks Like

• Ramps quickly to independent execution of the routine release test panel with consistently reliable results.
• Produces complete, accurate documentation with minimal corrections and supports an inspection-ready environment.
• Delivers certificates of analysis and release documentation accurately and on schedule.
• Recognizes and escalates atypical results early, contributing to effective investigation and resolution.
• Identifies backlog or process gaps proactively and offers to help before being asked.
• Builds cross-training toward serving as a qualified backup for select QA functions, strengthening team resilience during absences or surges.
• Expands assay capability over time and eventually supports training of peers on routine methods.

Who This Role Is Ideal For

This role is ideal for candidates who enjoy hands-on bench work, takes documentation seriously, and wants to build a quality control career across cell therapy, and cosmetic product lines in a growing company. This role is a great fit for someone energized by variety, equally comfortable with benchwork and cross-training to support the team in a fast-paced, dynamic environment. It is a mid-level individual contributor role with potential future growth into method development and validation support; candidates seeking a senior, lead or supervisory title may find it misaligned with expectations.

Compensation and Benefits

• Base salary of $65,000.00 to $78,000.00 annually, depending on experience and qualifications.
• Equity participation in a pre-revenue, high-growth biotech.
• Group Anthem medical, dental, and vision coverage, with 85% of premiums paid by AIVITA.
• Company-paid basic life and AD&D insurance, plus short- and long-term disability coverage.
• 401(k) with company match up to 6% of eligible compensation.
• Flexible Unlimited Time Off designed for responsible use, supporting work–life balance while meeting team and business needs.
• Professional development support, including courses and internal training aligned with your role and the company's growth.
• Broad hands-on exposure across cell therapy and other programs, with mentorship from Quality leadership.
• A highly collaborative culture and a famously well-stocked snack cabinet to keep you energized.

How to Apply

Please submit your resume and a brief note via cover letter describing your cGMP quality control and analytical testing experience, and why you are interested in joining AIVITA Biomedical.

Apply here: Quality Control Analyst @ AIVITA BIOMEDICAL INC

AIVITA Biomedical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employ