Quality Specialist - Specialty Pharmacy

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 HealthCare™ 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 And More! Hours: Monday through Friday 8am to 4:30pm

JOB SUMMARY

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.

REQUIRED EDUCATION AND EXPERIENCE

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Works closely with the Quality Coordinator and may at times carry out duties including testing, environmental monitoring, air and surface sampling, and other required testing. Assists in performing employee competency checks including garbing, hand hygiene, fingertip, and bubble pointing tests. Performs reviews of equipment maintenance, validations, and other reviews as necessary. Understands and follows cleaning and disinfection procedures for all work areas. Assists in media fill process validations, including inspection of filled units. Ensures personnel compliance with all quality programs. Informs management of critical compliance, regulatory or process findings that may negatively impact quality assurance. Observes processes including cleaning and environmental monitoring testing. Performs root cause analysis assignments, including investigation, research, analysis, and documentation. Creates and implements performance improvement initiatives. Completes thorough documentation of all assignments—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, including equipment calibration and maintenance, training, deviation and compliant investigation, environmental monitoring, Certificate of Analysis, clean room certifications, etc. Writes, distributes, and maintains quality policies related to operations and production. Reviews the implementation and efficiency of quality systems. Serves as a resource to operations regarding equipment and facility validations, calibrations, and unexpected events. Serves as a liaison to Information Systems to facilitate innovation and continuous improvements in Quality Management Systems development. Works closely with the Quality Coordinator, under the direction of the Quality Manager. Recognizes patients’ rights and supports them in the performance of job duties; respects patient’s privacy and confidentiality. Completes assigned paperwork/documents as directed in a timely manner. Shares knowledge with other staff members and works as a team member. Interacts with others in a positive, respectful, and considerate manner. Performs other job related duties as assigned.

QUALIFICATION REQUIREMENTS

Required to take Quality Analyst, Quality Auditor, or Six Sigma certification exam within 2 years of employment. Working knowledge of pharmaceutical processes. At least one year of working knowledge of quality assurance or quality control processes. Knowledge or ability to quickly learn commonly used concepts, practices and procedures within the pharmaceutical field. Excellent interpersonal skills, including strong communication skills. Strong analytical and problem solving abilities. Ability to communicate effectively and professionally with coworkers across disciplines and with multiple levels of employees. Ability to work in a team environment while delivering independent results. Demonstration of extreme attention to detail and accuracy. Ability to prioritize and meet deadlines. Resourceful, flexible, and well organized. Advanced computer proficiency with ability to work with IS to further develop databank needs. Knowledge in the use of Microsoft applications. #J-18808-Ljbffr Hirebridge