Join our team
SalubrisBio currently has 3 full-time employees and 3 part-time employees, and is in the process of recruiting talented professionals to form a team of 20 full-time employees by the end of 2018.
Quality Assurance (QA) Specialist

Benefits
The company offers competitive benefits including medical, dental, vision, short/long term disability and life insurance, as well as 401(k) match and paid time leave. SalubrisBio is an equal opportunity employer. Please contact Liping Yuan at liping.yuan@salubrisbio.com

Responsibilities and Duties

  • Establish and improve Quality Assurance (QA) system and provide quality expertise
  • Conduct quality review, audit, and tracking for processes, procedures, and data from CMO and CRO with GMP compliance
  • Review and approve Standard Operating Procedures (SOPs), batch record, CofA, etc.
  • Draft and review audits, quality plans, quality agreement and other quality related reports
  • Manage quality systems including change control, deviation, training, document control
  • Participate in or lead quality related investigations for process or product or testing
  • Analyze and write deviations and reports and further recommend corrective actions
  • Serve as a resource for staff at Gaithersburg site on issues pertaining to product quality
  • Responsible for ensuring compliance to applicable quality regulations and standards
  • Play an individual role in a multifunction project team

 

Qualifications and Skills

  • Education: BS or MS in Chemistry, Biochemistry, Chemical Engineering
  • BS with 9+ or MS with 7+ years of FDA regulated industry experience in quality assurance for biotherapeutic drug product development
  • Strong background in US FDA regulations with cGMP compliance in support of biopharmaceutical manufacturing operation
  • Ability to independently conduct quality audit and review of processes, procedures and data
  • Hands-on experience in analytical development and/or process development is preferable
  • Knowledge of quality assurance concepts and practices and managing basic quality systems, such as change control, deviation reporting, training, and document control
  • Knowledge of Quality Control for biotherapeutic drug product development
  • Strong verbal and written communication skills
  • Self-motivated, well organized, and highly effective in team-oriented environment

 

 

August 19, 2019 Back