Specialist QA AFP

Location: Thousand Oaks, CA
Date Posted: 07-17-2017
Day to Day Responsibilities:
• Authorship and Maintenance of of the Quality Management System documentation
• Lead initiatives to ensure the assigned quality process is in alignment with applicable regulatory requirements.
• Oversee, and in some areas implement, required actions to drive expected program performance.
• Monitor, evaluate and executes required changes to ensure organization’s success in managing the Quality Management System.
• Utilize leadership skills to successfully influence outcomes, communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting
• Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to assigned processes.
• May lead the planning and facilitation of Network meetings.
• Responsible for executing required data analysis, such as trend analysis and initiating required action to manage any identified area of concern.

Description
This position is on-site at Thousand Oaks M-F core hours of 8am- 5pm with possibility of late meetings to cover the Singapore and Australia offices. Ideal candidates have strong working knowledge of Quality Management System regulations including: ICH Q9, ICH Q10, ISO 13485, FDA and EMA regulations. Previous on hands experience managing Quality Management System in biologics or medical device industry. Experience managing investigation, conducting root cause analysis and leading implementation of improvement actions. Ideal candidate can interpret the needs based on the incoming regulatory changes and how it impacts the business. Great communication skills both verbal and written, leadership skills is also a must as they will lead meetings with high level leadership.

The Specialist of Quality Assurance Contingent Worker is a temporary staff that will serves as a key expert for the Corporate Quality Assurance team supporting implementation and execution of projects to ensure an adequate, sustainable and effective QMS in Operations

Responsible for the maintenance assigned quality processes, training maintenance and deployment, monitoring program performance, executing analysis of information and ownership and/or approval of assigned quality records for the corporate functions. Program support responsibilities will also include the continued advancement of improvements to sustain the process alignment with all applicable requirements.

Basic Qualifications
Doctorate degree OR Master’s degree & 3 years of Quality experience OR Bachelor’s degree & 5 years of Quality experience OR Associate’s degree & 10 years of Quality experience OR High school diploma / GED & 12 years of Quality experience

Preferred Qualifications
Strong working knowledge of Quality Management System regulations including: ICH Q9, ICH Q10, ISO 13485, FDA and EMA regulations
Previous on hands experience managing Quality Management System in biologics or medical device industry.
Experience managing investigation, conducting root cause analysis and leading implementation of improvement actions
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
Strong problem solving, investigation and root cause analysis skills
Ability to converse technically with mechanical, electronic, software, and quality engineers
Ability to work on multiple projects within a deadline-driven environment
Strong oral and written communication skills, decision making, presentation and organization skills
Experience in project management, process improvement, performance management and quality system management
Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach
Organizational savvy and presence to build effective relationships across functions

"This posting is for Contingent Worker, not an FTE"
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