Quality Specialist - Specialty Pharmacy

About the role

AIS Healthcare is the leading provider of Targeted Drug Delivery (TDD) and Infusion Care. Our diverse culture and values of Innovation, Stewardship, and Unity drive us to advance quality and improve lives. We provide quality products and services that enhance the entire care experience.

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.
• Reviews 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.
• SUBMITTED 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 LIASON TO INFORMATION SYSTEMS TO FACILITATE INNOVATION AND CONTINUOUS IMPROVEMENTS IN QUALITY MANAGEMENT SYSTEMS DEVELOPMENT.
• WORKS CLOSER 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 PAPERS/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.

Qualifications

• 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.

Benefits

• 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!

Pay

• Not specified

Schedule

• Monday through Friday 8am to 4:30pm