Quality Specialist

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.

Summary:

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.

Primary 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

Additional Responsibilities:

• 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.

Knowledge, Skills, & Abilities:

• 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

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.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.   Occasionally walks and stands. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate 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.  Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85 

Learn more about Grifols