Associate, Quality Assurance

**We are Growing** Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity
- **Associate, Quality Assurance**

**Overview**
- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
- Development and worklife balance: We want our employees to develop personally as well as professionally.

**Responsibilities**:

- Assist in the review of Biorasi quality systems, processes, and procedures for compliance with applicable Regulatory regulations and ICH guidelines and propose and assist in implementation of targeted quality improvements.
- Review all Biorasi Standard Operating Procedures, Forms and Templates for compliance, format and structure with a focus on QA and GN SOPs.
- Assist with Regulatory Inspections and Sponsor Audits, Internal, Investigator, and Vendor Quality Assurance Audits.
- Assist with the development, initiation, and facilitation of Quality Assurance training programs.
- Maintain overall control of central filing rooms/cabinets facilitating access to study documents retained in-house, transfers to Sponsors or off-site storage facilities, and document destruction programs.
- Write, review and/or revise QA SOPs.
- Assist the Document Control: troubleshoot issues, assist and advise staff.
- General coordination and facilitation of development programs, setting up training rooms, technology and other functions as needed, prepare and order educational aids and materials. Facilitate and or conduct development sessions.
- Maintain updated training and development matrix, the curriculum database and assign SOPs, trainings and development to staff, and track completion.
- Assist in the management of Employee training and development files for new hires, as well as maintaining compliant ongoing training and development documentation for existing employees.
- Assist in the creation, enhancement and implementation of training tools and delivery methodologies.
- Assist in the design of development programs and their associated assessments. Assign training and development identifier to newly developed materials and update the training and development matrix and curriculum catalogue.
- Assist in the evaluation of performance and effectiveness of training programs, including recommendations for improvement.
- Associate I: Bachelor’s degree is a plus but not required with combination of work experience and knowledge in industry for a minimum of 1 year.
- Associate II: Bachelor’s degree is a plus but not required with combination of work experience and knowledge in industry for a minimum of 3 years.
- Language Skills; Fluent English (oral and written)
- Strong problem solving, management and leadership skills.
- Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
- Excellent verbal, written communication, and presentation skills
- Computer literacy.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.