Quality Analyst

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Full Time Coraopolis, PA, US

Purpose:

The Quality Analyst reports directly to the Program Manager and plays a critical role in ensuring the program team is compliant with the quality and data metrics set forth by the manufacturer of one of Vanscoy Rare's dedicated programs. This role will monitor program activities to ensure compliance with all operating procedures, execute random and scheduled internal audits, facilitate various strategic quality improvement initiatives and evaluate ongoing effectiveness.

The Quality Analyst will oversee audit call monitoring, review program performance, and will work closely with the Program Manager to identify trends in order to achieve high quality predictable results and optimal outcomes. This role will also be responsible, for any Call Calibration touchpoints with the manufacturer and Vanscoy Rare .

Responsibilities:

• Monitor compliance within the program SOPs, work instructions, call guides, completion time, and ensure adherence to quality expectations.
• Review, analyze, and follow-up on team processes to ensure all actions and tasks are compliant with program SOPs, Work Instructions and update as appropriate . Make recommendations to accomplish activities with the utmost efficiency.
• In collaboration with the program leadership, assist in the development and delivery of onboarding, training, initial certification and maintaining records of annual trainings and recertification, including but not limited to, Adverse Event, Motivational Interviewing, updates and revisions to business, regulatory and compliance rules, and any operational changes related to program quality monitoring.
• Review adverse events and product complaints for accuracy and submit completed reports to appropriate third parties per business rules
• Perform ongoing scoring, calibration, evaluation of recorded inbound and outbound calls and corresponding documentation to ensure quality program standards are met.
• Responsible for identifying and monitoring trends from call monitoring and recommending process improvements when necessary.
• Meet with internal and external audiences to identify and problem solve Quality Improvement (QI) issues. Responsible for providing feedback on call monitoring and calibration results to Program Manager and manufacturer.
• Work independently to set quality program expectations related to delivering excellent customer service.
• Ensure quality measures are maintained by supporting the leadership and compliance teams in implementation of recommendations, keeping in mind adherence with documented current business rules, SOPs and work instructions.
• Perform quality documentation audits on patient files to evaluate if information was processed according to program SOPs.
• Monitor to ensure validity of defined data and reports. Collaborate across internal program teams and external departments to ensure accuracy and timely delivery to receiving parties. Investigate and identify root cause analysis of any contributing factors which may cause delays or barriers.
• Organize, compile, and report QI data to identify trends, establish priorities, and recommend improvement activities.
• Facilitate any external program audit request in collaboration with leadership and Vanscoy Rare compliance team. Act upon any request for recommended revisions within the required timeframe (usually 30 days).
• Independently manage and prioritize multiple project work streams to meet deadlines.
• Lead and participate in additional Quality & Special projects as needed upon request.
• This position may require flexibility in scheduling, with shifts…