Principal Quality Associate, QA, General Computer Systems

Grifols•Clayton, NC

11d•Onsite

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

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.

Responsibilities

Lead and support data integrity risk assessments, gap assessments, and remediation activities for GxP computer systems used in Manufacturing and QC Laboratories.
Provide Quality oversight for user access management, role-based security, audit trail review, and electronic records/electronic signatures controls to ensure compliance with 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements.
Review and approve validation lifecycle documentation for computerized systems, including risk assessments, validation plans, test documentation, traceability, deviations, and final reports.
Partner with system owners and business stakeholders to ensure validated systems remain in a state of control through change control, periodic review, configuration management, and ongoing compliance monitoring.
Serve as a Quality SME during regulatory inspections, internal audits, and investigation/CAPA activities related to computerized systems and data integrity controls.
Support any compliant requirements of FDA audits, internal and external audits and regulatory affairs commitments.
Support Change Control requests for manufacturing and laboratory computer systems.
Demonstrated ability to independently make sound quality decisions.
Demonstrated ability to influence decisions makers in other departments
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.