Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
SHIFT: Day
Location: Clayton, NC
Sr. Quality Associate I/II (M08/M09) / Principal Quality Associate (M10), QA General Computer Systems
The person in this role will primarily support site Data Integrity Initiatives for GXP computer systems used in Manufacturing and QC Laboratories and provide Quality Assurance oversight and document review for computer system validation for the QC Laboratories. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. Serves as delegate to the manager.
Responsibilities:
Additional Responsibilities:
In addition to the duties described above, the Principal Quality Associate may also perform the following duties based upon the business unit to which he/she is assigned:
Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings, and project meetings.
Knowledge Skills and Abilities
Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently.
Sr. Quality Associate I- BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
Sr. Quality Associate II- BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
Principal Quality Associate-BA/BS degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS is required. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment is required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Able to communicate complex 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. Perform tasks by following a set of written or oral instructions/procedures.
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, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]
Learn more about Grifols
Are you passionate about making a difference in the world? At Grifols, we are pioneers in the development of therapies derived from blood and plasma. We contribute to building the future of healthcare to improve people's well-being. Since 1909, we have been defined by passion, innovation, teamwork and a sense of responsibility. Our people change lives while growing and developing into a forward-looking international company.
At Grifols, you will be part of a growing international team of more than 23,000 people in more than 30 countries and regions with a common goal: to improve people's lives. You will contribute to developing scientific advances and providing innovative solutions for healthcare professionals and essential medicines for patients. We want to count on determined professionals who, by cultivating their talent, contribute to creating a positive impact on society.