Quality Specialist - Specialty Pharmacy

RXinsider LTD.; Dallas, Northern (TX, KY); Hybrid; USD 52,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with employer contribution

Job summary

AIS Healthcare is seeking a Quality Specialist to support the Quality Manager in implementing and managing the Quality Department. The role includes testing, data analysis, and root cause investigations to drive improvements.

The candidate will train staff, perform audits, and ensure compliance with USP and industry standards, while documenting results and supporting continuous quality initiatives.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Toxicology, Nursing, or related field.

Responsibilities

• Works with Quality Coordinator; performs testing including Environmental Monitoring and air/surface sampling.
• Performs employee competency checks and equipment maintenance reviews.
• Follows cleaning/disinfection procedures and validates media fill processes.
• Conducts root cause analyses, documents findings, and implements performance improvements.
• Maintains quality records, conducts audits, and prepares reports.
• Provides training on quality initiatives and ensures regulatory compliance.

Skills

Quality Assurance

Quality Control

Environmental Monitoring

Root Cause Analysis

Data Analysis

Documentation

Training

Regulatory Compliance

Microsoft Office

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Toxicology, Nursing, Clinical Laboratory Science, or related field

Master’s degree preferred

Tools

Microsoft Office

Job description

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 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
• Career growth opportunities
• And More!

Address: 18451 Dallas Parkway, Dallas, TX 75287

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 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, 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 responsibilities and supports them in the performance of job duties; respects patient’s rights to privacy and confidentiality. Completes assigned paperwork/documents as directed in a timely manner. Shares knowledge gained 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 a 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 also delivering independent results.
• Demonstrate extreme attention to detail and accuracy.
• Ability to prioritize and meet deadlines.
• Resourceful, flexible, and well organized.
• Advanced computer proficiency with the ability to work with IS to further develop databank needs.
• Knowledge in the use of Microsoft applications.