Quality Specialist - Specialty Pharmacy

This is an onsite role:

AIS Healthcare is the leading provider of Targeted Drug Delivery (TDD) and Infusion Care With our diverse culture, and our values around Innovation, Stewardship, and Unity, we are committed to Advancing Quality and Improving Lives. We are dedicated to doing more for our patients by providing quality products and services that enhance the entire care experience.

AIS Health Care is the leading provider of advanced sterile, patient-specific intrathecal pump medications and in-home intravenous infusion, including immune globulin therapies. These services, combines with your advanced nursing and care coordination solutions, assist physicians and hospitals in delivering a superior level of care for optimal therapeutic outcomes.

We foster a positive work culture and are seeking a motivated, detail-oriented team member who is committed to excellence and teamwork.

AIS Healthcare offers a comprehensive benefits package, including:

• Health, vision, and dental insurance
• Long-term disability and life insurance
• Competitive PTO
• 401(k) with a generous employer contribution
• Career growth opportunities
• And More!

Address: 18451 Dallas Parkway, Dallas, TX 75287

Hours:

Monday through Friday 8am to 4:30pm

This position is responsible for assisting the Quality Manager in the implementation and management of the Quality Department. The Quality Specialist is also responsible for testing, observing processes, gathering and analyzing data related to quality measures, investigating quality issues, assisting in the performance of root cause analyses, identifying training needs, and organizing training interventions to meet quality standards. This position organizes the data gathered in a meaningful way to interpret results and create initiatives.

• Bachelor of Science in Biology, Microbiology, Chemistry, Toxicology, Nursing, Clinical Laboratory Science, or related field required; master’s degree preferred.
• Training and experience in quality or performance improvement strongly preferred with quality assurance or quality control experience required.
• Clinical, industrial, or analytical processes troubleshooting experience strongly preferred.

Works closely with the Quality Coordinator and may at times, carry out those duties which include, but are not limited to:
Performs testing, including Environmental Monitoring, Air and Surface Sampling or other testing, as needed. Assists in performing employee competency checks including, garbing, hand hygiene, fingertip, and bubble pointing tests as needed. Performs reviews of equipment maintenance, validations, and other reviews as necessary. Understands and follows cleaning and disinfection procedures for all work areas. Assists in the media fill process validations to include inspection of filled units.

Ensures personnel compliance with all quality programs. Informs management of critical compliance, regulatory or process findings or observations which may negatively impact quality assurance. Observes processes including, but not limited to, cleaning and environmental monitoring testing. Performs Root Cause Analysis assignments including the investigation, research, analysis, and documentation of the assignment. Creates and implements performance improvement initiatives. Completes thorough documentation of all assignments, including, but not limited to, testing, monitoring, sampling, observations, competencies, analyses, inspections, reviews, and initiatives related to quality control.

Works with the Quality Manager to continuously improve the quality program by evaluating supporting documentation to ensure compliance with USP , industry standards, and other applicable regulations. Communicates and interprets quality guidelines effectively with coworkers and customers. Participates on project teams and provides necessary support to meet required deadlines, working with teams and partnering to facilitate continuous improvement. Reviews records, performs internal audits, desk audits, and recommends corrective action.

Performs routine trend analysis, compiles information, and develops reports, as assigned. Provides training to all personnel to ensure all quality initiatives are properly understood and followed. Submits samples to the appropriate lab for testing and analysis. Maintains quality records. (Equipment calibration and maintenance, training, deviation and compliant investigation, environmental monitoring,…