What are the responsibilities and job description for the Quality Control and Process Specialist position at Grifols?
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.
Primary 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
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
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.
Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
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