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Research & Development
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United States
Thanks for your interest in the R&D Quality Associate position. Unfortunately this position has been closed but you can search our 698 open jobs by clicking here.

A fantastic opportunity is available for a Quality Associate to join our Research & Development Quality team.

  

 

This role is responsible in

 

 

  • Ensures that the Quality Management System complies to current GXP standards and internal RB requirements
  • Ensures compliance of the local QMS with the RB Business Management System at the local site level
  • Implements the annual internal and external audit schedule, conducts audits, provides suggestions for improvement and monitors completion of CAPA actions
  • Is responsible for the coordination and publishing of the defined Quality Management System metrics(KPIS) locally on a monthly basis and ensures that they are systematically communicated to the R&D Team
  • Monitors internal compliance trends to identify areas of improvement and working with the R&D Team enables key improvement initiatives are identified and implemented
  • Approval and improvement of GMP related SOPs, Batch Manufacturing Records and validation documents
  • Review and Approval of change control, deviations and out of specification records 
  • Provides Training  to RB staff on – GMP and GCP Induction, delivers Annual GMP Refresher training and other specific quality related training  in line with the standards defined in the QMS
  • Links with Global Quality Compliance and Supply QA to maintain alignment and best practices to Global standards
  • Prepares for, and takes an active part in managing  inspections by regulatory authorities and internal RB audits
  • Monitors and manages performance to CAPA resulting form regulatory inspections
  • Provides quality input into development projects at an operational level enabling progress and improvements that realise product launch
  • Proactively monitors and responds to changes in guidance and legislation issued by Regulatory Authorities.

 

Key Challenges

  • Proactively monitoring and implementing changes to the local QMS
  • Maintaining a balanced compliance culture while delivering the business needs- partnering with the local R&D Teams where everyone takes ownership for quality is essential to the success of this role
  • Works with Category Teams on projects to ensure timelines are met in line with current regulatory and internal standards
  • Ensures QMS metrics are systematically published and proactively improved using excellent communication tools.
  • Participates in the local Management review programme
  • Comfortable evaluating and implementing risk evaluation and management activities is a significant part of the role
  • Development and maintenance of “leading edge” quality management systems in alignment with best practice
  • Maintain awareness of broad activities of R&D, Marketing and Supply, integrating quality systems as required for product regulatory compliance
  • Interacting cross functionally to ensure a “seamless” product launch

Is this You?

  • Good degree in a relevant scientific discipline
  • Lead Auditor trained
  • 6+ years experience within Healthcare/FMCG multidisciplinary environment
  • Quality system design, implementation and monitoring  experience
  • Previous experience of using Quality System tools such as Trackwise
  • Very broad knowledge of regulatory requirements at an international level
  • Understanding of the activities of R&D and a broad understanding of the product life cycle
  • Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define, evaluate and take risks
  • Global mindset, commercial understanding of corporate and operational business issues
  • Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action
  • Excellent communication skills, both written and oral
  • Proven ability to work under pressure without compromising on deliverables
  • Understanding of strategy and planning issues, consumer understanding, priority setting and project management
  • Capable of building strong working relationships and motivating teams to deliver outstanding results with or without hierarchical relationships
  • Commercial understanding of corporate and operational business issues


 

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.

 

Apply Now for a chance to really change the game!

 

 
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

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