Quality Specialist - Specialty Pharmacy

AIS Healthcare•Dallas, TX

8d•Onsite

About The Position

AIS Healthcare is a leading provider of Targeted Drug Delivery (TDD) and Infusion Care, committed to Advancing Quality and Improving Lives through a diverse culture and values of Innovation, Stewardship, and Unity. They offer quality products and services to enhance the patient care experience. AIS HealthCare specializes in advanced sterile, patient-specific intrathecal pump medications and in-home intravenous infusion, including immune globulin therapies, supported by advanced nursing and care coordination solutions. The company fosters a positive work culture and seeks a motivated, detail-oriented team member dedicated to excellence and teamwork.

Requirements

Bachelor of Science in Biology, Microbiology, Chemistry, Toxicology, Nursing, Clinical Laboratory Science, or related field required.
Training and experience in quality or performance improvement strongly preferred.
Quality assurance or quality control experience required.
Clinical, industrial, or analytical processes troubleshooting experience strongly preferred.
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.

Nice To Haves

Master’s degree preferred.
Training and experience in quality or performance improvement strongly preferred.
Clinical, industrial, or analytical processes troubleshooting experience strongly preferred.

Responsibilities

Assisting the Quality Manager in the implementation and management of the Quality Department.
Testing, observing processes, gathering and analyzing data related to quality measures.
Investigating quality issues and assisting in root cause analyses.
Identifying training needs and organizing training interventions to meet quality standards.
Organizing gathered data to interpret results and create initiatives.
Performing testing, including Environmental Monitoring, Air and Surface Sampling.
Assisting in performing employee competency checks (garbing, hand hygiene, fingertip, and bubble pointing tests).
Performing reviews of equipment maintenance, validations, and other necessary reviews.
Understanding and following cleaning and disinfection procedures for all work areas.
Assisting in the media fill process validations, including inspection of filled units.
Ensuring personnel compliance with all quality programs.
Informing management of critical compliance, regulatory, or process findings that may negatively impact quality assurance.
Observing processes, including cleaning and environmental monitoring testing.
Performing Root Cause Analysis assignments, including investigation, research, analysis, and documentation.
Creating and implementing performance improvement initiatives.
Completing thorough documentation of all assignments (testing, monitoring, sampling, observations, competencies, analyses, inspections, reviews, and initiatives).
Working with the Quality Manager to continuously improve the quality program by evaluating supporting documentation for compliance with USP <797>, industry standards, and applicable regulations.
Communicating and interpreting quality guidelines effectively with coworkers and customers.
Participating on project teams and providing support to meet deadlines, working with teams to facilitate continuous improvement.
Reviewing records, performing internal audits, desk audits, and recommending corrective action.
Performing routine trend analysis, compiling information, and developing reports.
Providing training to all personnel to ensure quality initiatives are understood and followed.
Submitting samples to the appropriate lab for testing and analysis.
Maintaining quality records (Equipment calibration and maintenance, training, deviation and compliant investigation, environmental monitoring, Certificate of Analysis, clean room certifications, etc.).
Writing, distributing, and maintaining quality policies related to operations and production.
Reviewing the implementation and efficiency of quality systems.
Serving as a resource to operations regarding equipment and facility validations, calibrations, and unexpected events.
Serving as a liaison to Information Systems to facilitate innovation and continuous improvements in Quality Management Systems development.
Recognizing patients’ rights and responsibilities and supporting them in job duties; respecting patient’s rights to privacy and confidentiality.
Completing assigned paperwork/documents in a timely manner.
Sharing knowledge gained with other staff members and working as a team member.
Interacting with others in a positive, respectful, and considerate manner.
Performing other job-related duties as assigned.