Quality Specialist

GRIFOLS, S.A.

15d•Onsite

About The Position

Manages and supports Quality System activities to ensure effective communication, compliance, and continuous improvement across the organization. Assists with creating and maintaining quality system records (CAPAs, Deviations, Complaints, Change Controls, SOPs, returns, expired goods, KPI reports etc...) in accordance with regulatory requirements, Good Distribution Practices (GDP), and company policies and procedures.

Requirements

Proficient in Quality systems related to Good Distribution Practice
Applies critical thinking, attention to detail, and logical analysis
Strong organizational and project execution skills; ability to manage multiple priorities, tasks, and deadlines in a fast‑paced environment.
Ability to work independently with minimum supervision.
Demonstrates professionalism, trust, respect, and accountability while adhering to company policies, procedures, and regulatory requirements.
Communicates clearly, accurately, and respectfully in both written and verbal interactions, remaining open to feedback and others’ suggestions.
Supports team members at all levels, contributes to team success.
Follows appropriate chain of command and effectively navigates organizational processes to accomplish tasks.
Good Distribution Practice (GDP) and Food and Drug Administration (FDA) regulations knowledge is preferred
Expert in Microsoft Office Suite; familiarity with project management applications
Demonstrates strong technical writing skills to create clear, organized documentation that supports technical and quality requirements
Bachelor Degree in Pharmacy, Microbiology, Biomedical Sciences or other Life Sciences preferred
Minimum 4 years in a Quality Assurance environment.
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. 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.

Responsibilities

Manages the change control process to ensure change requests are completed within established timelines and follows up with task owners to ensure proper and timely closure in order to meet the KPIs requirements
Proactively reviews and assesses as the owner, the deviations, CAPAs, and distribution related complaints to ensure accurate reporting and documentation and follows up with responsible task owners to ensure timely and effective resolution in order to meet the KPIs requirements
Creates thorough written reports, when required, that summarize investigations driven from Deviations, CAPAs and Complaint
Manages, assesses and evaluates the tracking and trending of deviations, CAPAs and complaints to drive continuous improvement initiatives and stay in compliance
Manages and maintain records of returns, expired goods, record archival and LSQM documentation
Serves as the Training Coordinator (GTP and Manual Training) by establishing training profiles for affiliate employees and distributing and managing training responsibilities that must be processed manually for affiliate personnel.
Maintains the Approved Supplier List and supports other Grifols divisions (domestically and globally) to ensure compliant Quality Management Systems and GDP alignment.
Maintains the Medicinal Customer List
Participates and presents in departmental and cross functional team meetings and/ or assemble cross functional teams and/or facilitate team meetings as necessary.
Assigned additional responsibilities as needed
Writes Standard Operating Procedures based on corporate documents, audit findings, or business needs.
Strict adherence to procedures and practices according to FDA regulations.
Create KPIs reports to support the Management Meeting.