Quality Management System Specialist

Personalized, cell-based therapy is emerging as a paradigm-shifting strategy in healthcare. To harness the potential of cutting-edge cellular engineering, stringent process controls must be put into place that monitor and measure critical parameters of the cell product at every step, from patient sample acquisition to drug product release. In essence, the process is the product.

 

The Accellix system offers a streamlined workflow solution that couples automated sample preparation within a single-use microfluidic cartridge, customized ambient-stable reagents, high sensitivity fluorescent event detection, and assay-specific auto analysis. The combination results in robust multiparametric analysis with ‘mix and read’ simplicity, enabling standardized process controls for engineered T-cells and other cell therapy products.

 

Summary of Work

We are seeking an energetic and enthusiastic individual to join our Quality Assurance team in the San Jose location. This individual will ensure that our processes are compliant with all relevant standards while we scale up the business and production operations to meet the growth in the coming years.

 

Essential Duties and Responsibilities (Other duties may be assigned)

  • Perform inspections according to internal policies, procedures, specification(s), drawing(s), and work instructions, ECO’s, Deviations, and other applicable controlled Quality System documents
  • Receive, inspect and release parts and raw materials such as solutions, chemicals, reagents
  • Performed inspections of product labeling and packaging
  • Perform component and functional testing
  • Review of completed batch record and LHRs to ensure GMP and GDP are followed
  • Initiate and investigate non-conformances
  • Manage training for San Jose Accellix employees and provide guidance to supervisors and employees to timely complete training
  • Manage equipment control program ensuring equipment are calibrated/maintained as scheduled
  • Oversee risk management procedures
  • Assist with customer complaints and CAPAs
  • Assist on supplier evaluation and maintenance of supplier files
  • Participate in audits and carry out corrective activities for closing audit findings
  • Gather and organize statistical quality data and identify areas for improvement
  • Interpret and comply with quality assurance standards Perform additional Quality Assurance duties as instructed by Manager

 

Qualifications and/or Experience

  • Bachelor’s degree or equivalence
  • Minimum of 2 years of relevant experience in Quality Systems and related aspects in Pharmaceutical/Biotechnology/Medical Device
  • Experience in Document Control
  • Knowledge and ability to write, review, and revise SOPs as required
  • Experience in managing Personnel Training program and conduct training as required

 

Skills & Abilities

  • Strong inter-personal skills
  • Excellent oral and written communication skills
  • Great attention to detail
  • Good organizational and time management skills
  • Able to work independently, identify issues and resolve proactively or seek guidance as appropriate and applicable
  • Proficient in Microsoft Office applications
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