Quality Assurance Specialist/Manager

The Regenerative Medicine Laboratory at the Tisch MS Research Center of New York is seeking a Quality Assurance (QA) Specialist to perform quality oversight of the cGMP manufacturing of autologous human cell therapy products currently undergoing clinical trial testing to treat multiple sclerosis. The position represents an exciting opportunity to join the Tisch MS Research Center of New York, an independent research center dedicated to finding the cause of and a cure for multiple sclerosis.

Main Job Tasks and Responsibilities

  • Responsible for quality oversight of cGMP cell therapy facility 
  • Implements and develops quality management system to meet cGMP standards and regulations
  • Continuously improves processes to ensure compliance and support growth of the organization 
  • Manages and applies an effective quality risk management program
  • Responsible for SOPs, specification controls, and change control programs 
  • Oversees in house auditing program, batch record review, and product release
  • Manages equipment maintenance schedules and files
  • Oversight of all production and analytical method validations and qualifications
  • Implements and enforces a comprehensive training program
  • Writes all technical reports for deviations, OOS, and CAPAs
  • Lead all investigations for non-conformities, supplier issues, etc
  • Work closely with production and QC personnel to ensure all activities under cGMP are documented and audited according to the cGMP requirements
  • Reinforces quality standards and performance

Education and Experience

·     Requires Bachelor’s degree and/or advanced degree in life sciences or related field

 

·     Minimum of 5 years of experience in cGMP manufacturing, quality assurance and/or quality control, or equivalent combination of education and experience

·     Ability to work independently with good time-management skills

·     Excellent communication and problem-solving skills

QA position is full-time and in-person, not remote. Tisch MSRCNY follows strict COVID-19 protocols to ensure the safety of all staff. We offer a very competitive salary and benefits in a pleasant and professional work environment. Names of 3 references must be provided on request.