CQA Quality Control & Process Specialist

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

Occupational Demands Form:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters

Learn more about Grifols