Quality Analytics and Validation Specialist

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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.

This is a remote position.

Summary:

The Lead Specialist of QA&V is responsible for deploying and maintaining the eProgesa Blood Establishment Computerized System (BECS) through the design and execution, of all aspects of software test activities including user requirement reviews, test methodology design, integration testing, regression testing and software QA&V activities. The Lead Specialist, QA&V will be responsible for developing and management of project plans ensuring the goals and objectives of each QA&V Department project are achieved on time and within budget. This individual will participate in the development and execution of user requirements as well as design and execute verification and validation test procedures.

Responsibilities:

• Design and execute validation projects of the QA&V Department ensuring the GBS Department meets its corporate goals.
• Assist with the development and maintenance of the GBS validation strategy, policies, and procedures.
• Develop and participate in the execution of software, hardware, and process validation protocols (per GBS business and compliance goals).
• Coordinate internal and external validation resources, monitor and report progress of each QA&V project, protocol, and report.
• Execute QA&V procedures and protocols in compliance with GBS requirements, user and manufacturer’s specifications and applicable government regulations.
• Train external and internal (GBS) personnel on basic QA&V principles, procedures, and protocols.
• Assist in the definition and implementation of continuous improvement processes within the QA&V department.
• Perform the collection, collation, validation and reporting of KPIs as captured from the BECS system.
• Other duties as assigned.
• Travel up to 25%.

PERSONAL ATTRIBUTES:

• The ability and desire to work in a fast-paced team environment, routinely interfacing with Operational, IT, QA, RA, and vendor personnel.
• Demonstrated ability to lead multiple projects simultaneously, set priorities, identify, and addresses unexpected outcomes, meet deadlines and project budget guidelines.
• The ability to lead cross-functional project teams to create and maintain aggressive deployment schedules.
• Demonstrate effective verbal and written communication skills.

QUALIFICATIONS:

Requirements:

• Bachelor's degree (B.S.) from four year college or university in biology, engineering, science, mathematics, statistics, or other technical field

Preferred Education and/or experience:

• Familiarity with Whole Blood and Source Plasma Donor Center Operations.
• Familiarity with Blood Establishment Computer Systems.
• Develop strategies to achieve organizational goals and promote process improvement.
• Knowledge of Database software; Design software; spreadsheet software and Word Processing software.
• Ability to define problems collects data, establish facts, and draw valid conclusions.
• Validation experience in a regulated industry (e.g. FDA 21 CFR 820, the Quality System Regulation, ISO, PPTA and EU).
• Experience in software testing, verification, and validation, including regression testing and defect management and tracking.
• Experience in writing User Requirements Specifications and Test Traceability Matrices.
• 3 Minimum years of experience.

Pay scale of $74,885.70 - $112,327.40 per year for California and Washington, $65,118.00 - $97,676.00 for Maryland, and New York, depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

Location: NORTH AMERICA : USA : Home Office || NORTH AMERICA : USA : NC-RTP || NORTH AMERICA : USA : TN-Memphis:USHOME - Home Address

Learn more about Grifols