Pharma/Biotech Quality Assurance Specialist:
Tunnell Consulting, Inc.

Tunnell Consulting, Inc.
Turesol, the staffing division of Tunnell Consulting, looks for top talent on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client's need a Pharma/Biotech Quality Assurance Specialist. Title: Pharma/Biotech Quality Assurance Specialist Responsibilities: Work in close collaboration with a senior Quality Assurance industry professional and a curriculum class designer to design and develop a course to introduce Quality Assurance in the Pharmaceutical / Biotech Industry to students in an academic institution. The course will address multiple topics including - what are the regulatory requirements that quality assurance must comply with? How are those regulatory requirements practically met by companies? What are the common and best practices and the examples not to follow? How does quality assurance apply to various stages of the pharmaceutical/biotech product development life cycle? Does it apply in the same way to a long-established, large company with multiple mature products and to an emerging company? What are quality management systems? What is the risk-based approach to compliance? The course will need to be designed and developed between mid-August and the end of October. The QA Specialist will design the course outline in conjunction with the senior QA industry professional and the curriculum class designer and will create the draft course material. This course material will be reviewed by various stakeholders including the senior QA industry professional and stakeholders of the academic institution. This is a remote position with travel as needed. Experience/Skill Requirements: Working knowledge of QA and quality management systems in the life science industry (pre-clinical, clinical, CMC during development and commercial operations). General knowledge and breadth are preferred over deep expertise in select QA areas. Experience with development of training material or SOPs/work instructions. Strong written communication and presentation skills. Experience with academic institutions is a plus. Education: Bachelor's Degree preferably in Science, Engineering, or Regulatory affairs/ Quality Assurance