Principal Quality Associate, QA, General Computer Systems

Grifols, S.A; Clayton (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Grifols, S.A. seeks a Principal Quality Associate to oversee data integrity initiatives for GxP computer systems in Manufacturing and QC Laboratories. The role involves reviewing validation documentation, and guiding change control and periodic review to ensure ongoing regulatory compliance.

The position requires a STEM degree with eight years of relevant experience for the Principal level, with senior levels demanding five or more years. Day shift; regular full-time employment.

Qualifications

• BS/BA in STEM discipline with minimum 5 years relevant experience for Sr. Quality Associate I/II; higher years for Sr. II and Principal.
• Experience with GxP computer systems and data integrity is implied by role.

Responsibilities

• Lead and support data integrity risk assessments for GxP computer systems in Manufacturing and QC Laboratories.
• Provide QA oversight for access controls, audit trails, and electronic records/electronic signatures to comply with 21 CFR Part 11 and EU Annex 11.
• Review and approve validation lifecycle documentation and collaborate with system owners to maintain controlled validated states.

Education

BS/BA in STEM

5+ years relevant experience

8+ years relevant experience for Principal

Job description

Principal Quality Associate, QA, General Computer Systems

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: TECHNICAL

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

Role: 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

• 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

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.

Qualifications

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 Conditions

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.

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.