Description

Under limited direction, this position is responsible for assisting in managing the review of quality systems and compliance in all areas of technical and clinical operations. This position serves as a resource to operations on quality and regulatory issues, and operational excellence/performance improvement. Participates in performance improvement initiatives through data and process analysis.

This position will have a hybrid work environment operating from the Tempe, AZ location 3 days per week and working from a remote/ at-home office 2 days per week.

DUTIES AND RESPONSIBILITIES:

• May assist with coordination of workflow, training, and mentoring of support staff, as required.


• Leads through example, demonstrating RITE Values in daily interactions with others.


• Serves as a resource to operations for daily problem solving and compliance issue resolution.


• Actively encourages and supports divisional use of process improvement tools and methodologies. Serves as an improvement resource to Operations. Supports process improvement in alignment with National Office driven to performance goals. Evaluates trends in compliance performance.


• Leads and/or participates in process mapping activities for new and revised processes. Participates in planning and change implementation to ensure quality at the source. Evaluates process changes to include pre/post implementation assessments where applicable.


• Plans, schedules and performs internal quality risk assessments to ensure critical processes are compliant. Prepares final assessment reports and communicates outcomes to divisional management. Facilitates process improvement activities for identified observations.


• Provides divisional support regarding deviation management processes. Ensures all assigned deviation management reports are accurate and timely. Conducts root cause analysis, reviews corrective actions, and ensures corrective actions are implemented and effective for the assigned deviation management event.


• Ensures requests for required regulatory licenses are submitted timely.


• Provides support to operations and reviews/approves process outputs such as validation.


• Hosts external inspections occurring onsite. Supports divisional operations management hosting external inspections occurring at remote locations. Facilitates root cause analysis and ensures corrective actions are implemented and effective.


• Assists in development of inspection responses. Prepares risk assessment documentation related to observations for internal review.


• Participates on the divisional review team to evaluate nonconforming products, materials, or test results and assesses the impact on external customers. Ensures required actions are implemented.


• Assists in the oversight of Clinical Trial Studies.


• Provides divisional support of safety management. Performs safety observations to ensure compliance.

Requirements

Knowledge/ Education

Bachelor's degree or equivalent combination of education and experience required.

Licenses/Certifications

Certification as a Medical Technologist or SBB preferred.

Experience

Four years related experience in a regulated industry required. To include:

• Two years in a quality, regulatory, and/or auditing environment.

Six months supervisory experience preferred.

Skills/Abilities

Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.

Must be able to maintain confidentiality.

Ability to work in a team environment and participate as an active team member.

Must have proficient computer skills.

Must have analytical, statistical, personal organization, and problem-solving skills.

Able to organize, prioritize, and execute a variable workload and multiple priorities.

Summary

About Us

Vitalant is one of the nation's largest nonprofit blood and biotherapies healthcare organizations, providing hospitals and patients across the U.S. a safe blood supply, specialized laboratory services, transfusion medicine expertise and world-renowned research. We have a network of 115 donation centers across the U.S. and host approximately 60,000 bl ood drives annually. Vitalant provides blood and special services to patients in more than 900 hospitals across the U.S. where millions of people depend on blood donations from our generous donors.

Vitalant is committed to fostering a diverse and inclusive workplace built on a foundation of respect, integrity, teamwork, and excellence. Through our DEI strategic plan, we create opportunities for employees of all backgrounds to feel valued, seen and heard. We believe this mission drives creativity and innovation, as employees experience an environment conducive to personal growth and career development.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to Careers@vitalant.org to let us know the nature of your request.

For more EEO information about applicant rights click here