Field Validation Specialist - West BU

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.

• 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.

• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:

• 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.

• Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:

• 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.

• 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.

• 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. 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 Form # 34:
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…