Clinical Trials Quality Control Specialist in ROCHESTER, New York at Rochester Regional Health

Job Title: Clinical Trials Quality Control Specialist

Department: Specimen Processing

Location: Onsite, Rochester, NY

Hours Per Week: 40

Schedule: Days; Monday - Friday

SUMMARY

The Quality Control Specialist is responsible for supporting and maintaining quality control standards for Clinical Trials Specimen Management (CTSM) and the Clinical Trials Laboratory. This role works collaboratively with the leadership team to help ensure consistent quality, compliance, and adherence to best practices within the laboratory.

RESPONSIBILITIES

• In coordination with leadership, maintains current knowledge of all applicable regulations, requirements, and standards related to quality control processes.
• Performs all work in accordance with requirements of regulatory agencies such as CAP, NYSDOH, CLIA, OSHA, ISO and ISBER.
• Participates in quality control investigations, root cause analysis, corrective/preventative actions, and process improvements.
• Works with leaders to develop and maintain quality dashboards, quality monitors, regulatory (CAP, NYSDOH) related tasks, key performance indicators and compliance.
• Performs routine quality control review of equipment validation and qualifications to ensure compliance.
• Performs QC for shipping, storage and routine samples and documents at a percentage determined by management.
• Participates in regulatory inspections and client audits by gathering required documentation and providing it to Quality Assurance for internal and external audits.
• Provides input to appropriate corrective and preventive actions of audit/inspection findings within allotted due date.
• Performs a routine check of employee training binders and continuing education to ensure they are maintained by team members.
• Reviews employee competencies to ensure completion of annual and semi-annual competency assessments of all applicable employees.
• Reviews Best practices and recommends and implements process improvements to streamline operations between the lab/CTSM and other departments.
• Leads and supports leadership with process rollout and staff (re)trainings
• Supports leadership by ensuring the development and updating of standard operating procedures, ensuring quality and regulatory compliance are present in the appropriate time frames.
• Promotes a culture of audit readiness
• Performs other duties as assigned

REQUIRED QUALIFICATIONS

• Associates Degree in science

PREFERRED QUALIFICATIONS

• Bachelor’s degree in science
• Good oral and written communication skills
• Good organization skills
• Good ability to work independently and in a team setting
• 4-6 years of experience in a Quality role within a clinical laboratory/ medical technology setting
• High school diploma or equivalent required

PHYSICAL REQUIREMENTS: M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.

PAY RANGE: $60,500.00 - $75,000.00

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, clinical licensure date, relevant qualifications, specialty, internal equity, location, and contracts.