Clinical Quality Assurance (CQA) Quality Control & Process Specialist

Grifols SA•Raleigh, NC

49d•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Requirements

Life Sciences Degree.
A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials.
Ability and willingness to travel.
Ability to work both in a team and independently.
Ability to meet deadlines, multitasks, and prioritize based on study needs.
Ability to works on assignments with a diverse scope.
Ability to work with a very limited direct supervision.
Advanced knowledge of ICH/GCP Guideline.
Advanced knowledge of electronic data capture (EDC) systems.
Advanced knowledge of medical terminology.
Advanced knowledge of the therapeutic areas assigned.
Routinely demonstrates mastery of technical skills

Responsibilities

Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans
Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures
Participate in the study plans reviews
Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report)
Provide quality oversight on the conduct of the clinical studies
Perform periodic quality reviews of the critical clinical procedures on the different clinical studies
Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues
Coordinate the management of study, internal and vendor deviations
Participate in the review of critical protocol deviations and Serious Breaches
Participate in project team internal meetings providing information about quality metrics of studies
Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies
Initiate the Quality Risk Assessment for every clinical study
Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies
Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies
Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable
Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies