Senior, Quality Control Specialist

AIVITA Biomedical - Irvine, CA

AIVITA is a fast-paced, biotechnology company located in the Irvine, California with programs in cancer immunotherapy, cosmetic, medical device, and contract manufacturing. AIVITA’s cancer immunotherapy division consists of a patient-specific immunotherapy platform technology applicable to most solid tumor types, currently being investigated in phase II clinical trials for melanoma and glioblastoma cancers, with plans to expand to other indications and potentially other geographies in the near future. AIVITA’s cosmetic division consists of stem cell manufacturing of the active ingredient for novel skin care products. AIVITA is developing a medical device kit to enable vaccine manufacturing at point of care using the patient-specific vaccine platform. As a contract manufacturer, AIVITA leverages our unique expertise in stem cell growth and directed high-purity differentiation to develop safe, efficient and economical manufacturing processes. In addition, AIVITA has ongoing R&D activities in cancer development and infectious disease.

Position Summary

AIVITA is seeking an immediate hire for full-time Senior QC Specialist that will support the manufacture and release of products for all programs. The candidate will report to the Company’s VP of Regulatory and Quality Assurance and will support continuous improvement of the Quality System for clinical, research and development, medical device, and cosmetic divisions. In this role you will work both independently and in cross-functional teams with manufacturing, quality, regulatory, and project management.

Responsibilities

• Assist in implementation of and adherence to cGMP, GLP and GDP
• Ensure accurate documentation of samples received for analysis
• QC & release manufactured intermediate and final products, includes clinical and R&D
• Analytical Assays: immunocytochemistry, flow cytometry, PCR, ELISA, ELISpot, endotoxin, sterility, Gram Stain, and cell counts by Coulter Counter, Cellometer and dye exclusion microscopy
• Lead process development, qualification and validation of analytical methods. Specifically, cell-based potency assay/bioassay, flow cytometry and ELISA methods
• Provide technical expertise, troubleshooting and assay execution for analytical methods
• Submission and communication with contract laboratories for outsourced testing
• Collaboration with team to plan experiments and execute protocols in support of process development and stability studies
• Independently generate, compile, and evaluate data for reports to support regulatory filings
• Writing technical study protocols, reports, and operational SOPs
• Completion, reporting, and generation of certificates of analysis/specifications for the release of products on schedule
• Conduct and manage laboratory investigations/quality events (CAPA, deviation, OOS, NCMR) and maintains accurate records in accordance with quality SOPs
• Maintain equipment for calibration and routine maintenance, familiar with IQ/OQ/PQ
• Ensure implementation of and adherence to Environmental Monitoring Program
• Daily equipment monitoring
• Daily cleanroom clearance prior to manufacturing use
• Maintain QC lab space and monitor stock levels of reagents
  
  

Requirements

• Bachelor’s degree, or higher in biological sciences or related field
• Minimum 2 years of experience in quality control or related field that includes experience with cell-based potency assay/bioassay, flow cytometry, ELISA and PCR methods
• Experience in cGMP/FDA regulated industry, highly preferred
• Knowledge of cGMP, ICH and FDA guidelines; familiarity with ISO 13485, a plus
• Experience in both early-phase qualification and late-phase validation
• Strong technical/analytical skills to identify and solve problems
• Proficient in MS Word, Excel, Power Point and other applications
• Strong work ethic, self-motivated and assertive with ability to work hands-on within given timelines
• Strong communication skills required to assist and collaborate with multidisciplinary groups in a dynamic team environment
• Able to manage multiple assignments and set priorities
• Excellent attention to detail and organizational skills to maintain a high level of productivity and record keeping
• Enjoys working in a fast-paced, small-company environment
  
  

The successful candidate will start full time employment immediately. Very competitive benefits package that includes medical, vision, dental, Life/AD&D, STD and LTD, FSA, HSA, 401K and a wellness incentive program.