Quality Control Analyst

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.

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.

• 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.

• 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.

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

• 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…