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Quality Assurance/Compliance Manager

Company: Associated Clinical Laboratories, L.P.
Location: Erie
Posted on: June 8, 2021

Job Description:

Utilize your skills to improve peoples lives.

ACL is searching for an energetic, self-motivated Quality Assurance / Compliance Manager to join our dynamic team.

  • Location: Peach Street

  • Full-Time; Exempt

  • Comprehensive Benefits Package including Paid-Time-Off

  • 401k

  • Corporate Bonus Program

Responsible for communicating, driving and proactively monitoring quality and compliance with all applicable federal and state laws, regulations, policy directives and ethical requirements at ACL.

Quality and Compliance Duties and Responsibilities:

  • Direct, advocate for and enable visibility of quality processes. Ensure accountability within all areas of the business unit.
  • Direct internal inspection process of the business unit to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and ACL standards.
  • Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) regulations and CAP accreditation standards for all sites.
  • Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
  • Prepare, revise and distribute a QA Manual that includes local QA policies. Ensure all applicable employees are trained and comply with policies. Ensures all QA policies have annual review.
  • Ensure performance of required Corporate Quality Surveillance Programs, Patient Results Distribution Program, Best Practice Team initiative/Database Changes Verification Program and other monitoring programs specially assigned by Medical Quality Assurance (MQA).
  • Ensure prompt and complete reporting of Reportable Quality Issues in compliance with Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable.
  • Ensure compliance with all MQA standards as required.
  • Provide leadership and advocacy in all compliance related areas including patient privacy requirements. Lead the Business Unit Compliance team.
  • Assist in the development and implementation of compliance education and training initiatives.
  • Communicate, implement, and monitor compliance policies/procedures and related change to the business.
  • Proactively monitor the Business Unit business practices to detect, promptly report and drive resolution of any potential violation of law, company policy, questionable practice or act.
  • Assist in the investigation of any reports or evidence of misconduct or non-compliance, and implementation of corrective action.

Experience, Education, and Licensure

  • Bachelor's degree (chemical, physical, biological or clinical laboratory science or medical technology) or equivalent experience.
  • Three years employment in a laboratory setting.
  • Experience with QA, statistical Quality Control, and laboratory regulations/accreditation requirements.
  • Experience with managing complex programs with accountability for measured outcomes.
  • Strong multi-tasking, communication, and project management skills.

Preferred Qualifications:

  • 5 years demonstrated leadership responsibility
  • Medical Technologist with 6 years experience
  • Certification by American Society of Clinical Pathologists (ASCP)(or equivalent) as an MT or MLT
  • Certification by American Society for Quality (ASQ)
  • Six Sigma Green Belt Training

Company Profile

ACL and our highly trained Team have worked with physicians and hospitals for over 30 years and we understand that in order to provide the best treatment possible, you will need access to the best medical testing and analysis. We strive to live up to our reputation to provide the highest quality and most efficient medical laboratory services to medical providers and patients in the communities we serve.

For New York Applicants click on the link below and read.

Article 23-A of the New York Corrections Code

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Keywords: Associated Clinical Laboratories, L.P., Erie , Quality Assurance/Compliance Manager, Other , Erie, Pennsylvania

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