Field Validation Specialist - West BU

Field Validation Specialist - West BU

Location:

Home Office, US Contract Type:
Regular Full-Time Area: MANUFACTURING Req

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 with up to 75% travel for Candidates on the West Coast of the United States.

Summary:

Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.

Primary Responsibilities:

• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry
• Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations
• Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use
• Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries
• Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues
• Writes test cases to validate critical control points, user requirements, and functional designs
• Executes test cases as needed
• Prepares validation reports for distribution
• Ensures milestones and timelines are met on assigned projects
• Prepares validation equipment for use at the Donor Center and for evaluation upon return
• Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service
• Tracks and monitors process/system failures/events
• Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes
• Tracks and monitors equipment calibration due dates and calibration failures/events
• Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes
• Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable
• Travels on-site up to 75% as needed to ensure timely validation completion within the Geo

Knowledge, Skills, and Abilities:

• Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures
• Excellent quantitative and analytical skills
• Excellent oral and written communication skills
• Strong critical thinking and problem solving skills
• Ability to identify errors and provide corrective action
• Ability to work with others in a team environment
• Knowledge of Microsoft Office applications and computer applications used in the Donor Centers

Education and Experience:

• Bachelor's degree
• Typically requires 2 years of quality and validation experience in a cGMP and/or IT 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

Occupational Demands:

• Work is performed in an office and a laboratory/manufacturing environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Exposed to occasional extreme cold below 32
  * and high levels of noise in production areas
• Exposure to electrical office and laboratory equipment
• Personal protective equipment required such as protective eyewear, garments and gloves
• Frequently sits for 4-6 hours per day
• May stand; bends and twists neck and waist for 2-4 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects
• Occasionally walks
• Repetitive foot movements
• Light to moderate lifting and carrying objects with a maximum lift of 50lbs
• Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye
• 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
• Performs tasks by following a set of written or oral instructions/procedures

The estimated pay scale for…