Clinical Trials Quality Control Specialist

Clinical Trials Quality Control Specialist Rochester, NY Job Details Full-time $60,500 - $75,000 a year 14 hours ago Qualifications Performance dashboard reports Regulatory inspections OSHA (regulatory compliance area) Dashboard development ISO standards Specimen collection / processing Regulatory compliance Compliance audits & assessments Corrective and preventive actions (CAPA) Mid-level Improving operational efficiency Laboratory staff training Quality assurance audits Laboratory regulatory affairs Staff training Quality improvement Laboratory quality control CLIA regulations Clinical trials Quality audits Training & development Root cause analysis 4 years Associate's degree Regulatory compliance management

Full Job Description 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 the oversight and management of quality control standards for Clinical Trials Specimen Management. The Quality Control Specialist will work collaboratively with the CTSM supervisors and Team Leads to ensure quality and best practices in the laboratory. This position reports to the Director of Laboratory Operations.

RESPONSIBILITIES

In coordination with Management keeps up with-current understanding of all applicable regulations, requirements and standards in regards 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 CT Lab and CT Specimen Management (CTSM) quality control investigations, root cause analysis, corrective/ preventative actions, and process improvements for the Lab and CTSM. Works with Lab and CTSM 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 collecting required documentations and provides to Quality Assurance for internal/ external audits for both the Lab and CTSM. 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 employees of both the Lab and CTSM. Reviews employee competencies in appropriate areas of the Lab and CTSM to ensure. completion of annual and semi-annual competency assessments of all applicable employees. Reviews Best practices for the Lab and CTSM space and recommends and implements process improvements to streamline operations between the lab/CTSM and other departments. Leads and supports Lab and CTSM leadership with process rollout and staff (re)trainings Supports Lab and CTSM leadership by ensuring the development and updating of standard operating procedures, ensuring quality and regulatory compliance are present in the appropriate time frames. Other duties as assigned by the manager Promotes a culture of audit readiness.

REQUIRED QUALIFICATIONS

Associates or Bachelor Degree in science

PREFERRED QUALIFICATIONS 4-6

years' experience in a Quality role within a clinical laboratory/ medical technology setting

EDUCATION

LICENSES /

CERTIFICATIONS:

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. For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements. Any physical requirements reported by a prospective employee and/or employee's physician or delegate will be considered for accommodations.

PAY RANGE

$60,500.00 - $75,000.00

CITY:

Rochester

POSTAL CODE

14624 The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts. Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.