Sr. Quality Associate II/III, QC, Laboratory equipment and software/computer system validation

Grifols, S.A; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Grifols, S.A in Clayton, NC is seeking a Sr. Quality Associate II/III to implement and maintain the Laboratory Electronic System (LES) within QC.

You will lead LES configuration, validation, and change controls, ensuring regulatory compliance and cross-functional collaboration across high-complexity assays. Responsibilities include overseeing system updates, supporting other computerized QC systems, and acting as a technical resource for troubleshooting electronic laboratory systems.

Qualifications

• Experience with electronic laboratory systems and computerized system validation.
• Working knowledge of QC laboratory test methods and workflows.
• Demonstrated experience with change control processes and software/computer validation activities.
• Strong analytical, documentation, and problem-solving skills.

Responsibilities

• Lead the design, configuration, and ongoing management of the LES, including defining required data elements and input parameters.
• Oversee validation activities for system updates, enhancements, and changes.
• Serve as a QC validation team member ensuring compliance with regulatory and internal standards.
• Support additional computerized systems within QC, including validation oversight and configuration.
• Act as a technical resource for troubleshooting electronic laboratory systems.
• Manage and document change controls related to software and system modifications.

Skills

Electronic LIMS experience

Software validation

Change control

QC workflows

Analytical problem-solving

Education

BA/BS in STEM

Tools

LIMS/LES

Job description

Sr. Quality Associate II/III, QC, Laboratory equipment and software/computer system validation

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: OPERATIONAL TECHNICAL AREA

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.

Schedule: First Shift

Sr. Quality Associate I/II:

Position Summary: This role is responsible for the implementation, maintenance, and continuous improvement of the Laboratory Information Management System (LIMS) used within the Grifols Therapeutics Quality Control (QC) department, referred to internally as the Laboratory Electronic System (LES). The LES supports the transition toward a fully paperless laboratory by electronically capturing all elements of the QC testing process across multiple high‑complexity assays.

Key Responsibilities:

• Lead the design, configuration, and ongoing management of the LES, including defining required data elements and establishing appropriate input parameters.
• Oversee validation activities associated with system updates, enhancements, and change implementations.
• Serve as a member of the QC computer validation team, ensuring compliance with regulatory and internal validation standards.
• Support additional computerized systems within the QC environment, including software validation oversight and custom field configuration.
• Act as a technical resource for troubleshooting and resolving issues related to electronic laboratory systems.
• Manage and document change controls related to software and system modifications.

Qualifications:

• Experience with electronic laboratory systems and computerized system validation.
• Working knowledge of QC laboratory test methods and workflows.
• Demonstrated experience with change control processes and software/computer validation activities.
• Strong analytical, documentation, and problem‑solving skills.

Education and Experience Requirements by Level:

Quality Associate III, QC - BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, projects, teams, etc. is recommended

Sr. Quality Associate I, QC - BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, projects, teams, etc. is recommended

Sr. Quality Associate II, QC - BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 6 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, projects, teams, etc. is recommended.

Equivalency: Depending on the area of assignment, directly related experience—or a combination of related education, experience, and competencies—may be considered in place of the stated requirements. For example, if a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

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.