Cell Therapy Development Specialist

1 week ago

San Francisco, California, United States Amerit Consulting Full time
Job Description

Overview:

Amerit Consulting, a leading staffing and consulting firm, is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our clients' cell therapy development and manufacturing activities.

Key Responsibilities:

  • Review research protocols to ensure compliance with federal, state, and university regulations and policies.
  • Assist in writing and reviewing protocols, and ensure compliance with regulatory requirements.
  • Perform quality assurance activities, including document management, supplier qualification, record review, report monitoring and tracking, deviation investigation, and other processes per established procedures.
  • Participate in the development and revision of standard operating procedures and guidelines.
  • Communicate directly with investigators to resolve concerns and ensure readiness for inspections and audits.

Requirements:

  • At least five years' experience in a quality role in an FDA-regulated industry, such as cell therapy, biotechnology, pharmaceuticals, or medical devices.
  • Independence, planning, and decision-making abilities to complete assigned duties.
  • Knowledge of relevant Federal and State regulations and policies.
  • Ability to solve problems and issues, listen, interpret, and confirm understanding of others' communications, and be objective.
  • Effective, efficient, and tactful oral and written communication skills.
  • Time management skills and the flexibility to accommodate changing priorities in the unit.
  • Ability to work in a team-oriented setting, prioritize work, and follow through on routine assignments with minimal direction.
  • Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
  • Strong organizational skills, the ability to multi-task, and work with frequent interruptions.

What We Offer:

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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