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Lead Quality Assurance Specialist
2 months ago
Are you interested in becoming part of a global team dedicated to enhancing healthcare outcomes? Grifols is a prominent healthcare organization that has been committed to advancing health and wellness since its inception in Barcelona in 1909.
With our four divisions - Bioscience, Diagnostic, Hospital, and Bio Supplies - we innovate, produce, and distribute cutting-edge medicines, solutions, and services across more than 100 countries.
Position Overview:
The Lead Quality Assurance Specialist is responsible for overseeing quality assurance functions, particularly in support of filling operations, while also providing utility support as needed.
Responsibilities will vary based on specific job assignments and may encompass tasks such as coordinating change control, reviewing manufacturing or testing documentation, preparing or evaluating failure investigations, conducting sampling/testing/data analysis, performing audits, and analyzing stability data.
This role requires a seasoned and technically adept professional who formulates and executes solutions to diverse quality-related challenges.
The individual may engage in teams or projects of varying complexity and is frequently sought after by colleagues for their expertise and guidance.
Key Responsibilities:
- Collaborates with management to provide expert advice and influence technical decisions across business units.
- Regularly interacts with management and, when necessary, with regulatory authorities.
- Participates in or leads cross-functional project teams with complex technical goals.
- Provides training and mentorship to team members.
- Reviews and approves validation processes.
- Prepares, reviews, and, in some cases, endorses SOP revisions, Change Control Requests, incident entries, and investigation reports.
- Upholds high standards of integrity and values.
- Effectively manages multiple tasks, prioritizes responsibilities, and adapts to evolving business needs.
- Prepares and reviews regulatory documentation.
- Contributes to the Annual Product Review and General Parameter APR documentation.
- Demonstrates the ability to independently make sound quality decisions with moderate guidance.
- Influences decision-makers in other departments.
- Engages in additional duties as assigned.
In addition to the aforementioned responsibilities, the Quality Associate may undertake advanced roles in various quality systems, including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, and Annual Product Reviews. They will also provide quality input for validation projects, capital engineering initiatives, clinical studies, stability studies, and regulatory submissions.
This role includes representing Quality at business unit and project meetings.
Qualifications:
A Bachelor’s degree in a STEM (Science, Technology, Engineering, and Mathematics) field is preferred, along with a minimum of 5 years of relevant experience or an equivalent combination of education and experience.
Work is conducted in both office and laboratory/manufacturing environments, with potential exposure to biological materials and infectious agents. Personal protective equipment is required.
Physical requirements include the ability to perform tasks involving frequent hand movements, light to moderate lifting (up to 35 lbs), and the capacity to communicate complex information effectively.
Grifols is committed to providing equal employment opportunities to all applicants and employees, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law.
We welcome all qualified applicants to apply in accordance with applicable state and local laws.
