Quality Assurance/Regulatory Affairs Manager

Quality Assurance/Regulatory Affairs Manager

 

 

Fort Lauderdale-based biological company established to collect source human plasma for use in the life-saving therapies with applications that include wound and burn treatment, immune deficiency and hemophilia and many others is currently accepting resumes for a Quality Assurance/Regulatory Affairs position.

 

This exceptional “ground floorâ€� (with significant growth opportunity) demands an individual whose role will be to implement and monitor quality systems and ensure that plasma is collected, tested, managed, and shipped in accordance with federal, state and industry regulatory guidelines.  Responsibilities include but are not limited to:

 

*Developing documents and standard operating procedures (SOP), including training SOP, to create a corporate quality management system

 

*Ensuring that procedures are written and implemented in accordance with all applicable regulations

 

*Instituting oversight procedures

 

*Directing vendor compliance

 

*Performing compliance assessments and audits

 

*Creating strategies to streamline operation

 

*Designing corrective measures to reduce potential for error

 

*Promoting awareness of industry developments and customer requirements throughout the organization

 

The ideal candidate for this opportunity will have a 4 year degree in a biology related field from an accredited college or university and 3 to 5 years of experience working in a blood or blood products facility in a QA/Regulatory Affairs capacity.  Background working in an FDA guided medical product or medical device industry is imperative as well as superior computer and communication skills and a flexible, team-oriented attitude.

 

Individuals with the desire and passion to become associated with a “young� and emerging

organization are invited to forward resume in confidence to: phoebe@hemarus.com