The QA/QI Specialist II supports and leads quality assurance and quality improvement activities by conducting monitoring efforts, maintaining dashboards and key indicator data sets, and analyzing outcomes to identify trends, risks, and opportunities for improvement. The role develops, implements, and evaluates quality improvement initiatives; performs complex audits and documentation reviews to assess compliance with applicable standards, regulations, policies, and procedures; and recommends corrective and preventive actions to address identified deficiencies and measure sustained improvement. This position also prepares teams for external audits and inspections through readiness assessments, evidence compilation, response drafting, and follow-up activities.
Primary Duties and Responsibilities- Carries out and/or leads monitoring efforts and populates dashboard and key indicator data sets.
- Develops, supports, and/or leads quality improvement initiatives; develops approaches to linking quality improvement to outcomes reported through dashboard or key indicator data or surveys and observation studies.
- Reviews documentation and assesses effectiveness of documentation review approaches; analyzes causes and develops solutions for documentation failures.
- Develops and carries out complex or qualification audits requiring content and operational knowledge of activity being audited to ensure compliance against standards, regulations, procedures and policies.
- Performs outcome analysis, including reviewing, interpreting, and reporting relevant information as assigned and presenting to physicians, investigators, leadership, or other stakeholders.
- Prepares teams for external audits and inspections. Performs readiness checks, compiles evidence, and drafts responses.
- Maintains employee records of training and credentialing as required by unit activity assigned and associated regulatory standards.
- Routes and revises controlled documents; prepares fillable forms, maintain records, and archives per retention requirements.
- Assists with correction and preventative action (CAPA) plans based on audit findings, deviations and events. Plans follow up audits to assess if the desired effect / change was achieved.
- Assists QA Manager in providing training, support, and supervision to QI-I staff.
- Provides training and support to relevant staff and clinicians in areas of expertise.
Knowledge, Skills and Abilities- Strong knowledge of applicable standards and regulations to ensure department/institution ongoing compliance with accreditation standards and inspection regulations.
- Subject matter expertise (e.g., donor services, data management, informatics, clinical operations, or other assigned program areas) to help the department/program achieve its stated objectives and goals for overall improvement.
- Strong Excel skills.
- Knowledge of medical, hematologic, oncologic, and scientific terminology preferred.
- Ability to compile data and analyze using statistical tools.
- Ability to understand the enterprise environment and competing priorities in conjunction with developing/meeting project goals.
- Strong project management skills.
- Strong written and verbal communication skills.
- Strong analytical and problem-solving skills.
- Attention to detail and interpersonal skills to effectively communicate with staff and physicians.
- Ability to work independently, manage multiple priorities, and adapt to change.
Minimum Job Qualifications- Bachelor's degree in a relevant field required.
- 4 years of experience in related field (cell therapies, clinical laboratory, research, clinical setting, biologic/pharma industry or similar) required.
- 2 years of quality assurance or advanced cell therapy experience (e.g., trainer, lead, senior or equivalent) in another area of specialization required.
License/Certification/Registration Required: None
Supervisory Responsibilities: No
Patient Contact: No
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$75,900.00 - $85,500.00
