MedLabs Diagnostics

Job Descriptions

Job ID: LT002
Department: Laboratory
Job Title: Quality Assurance Manager
Location: 85 Horsehill Road, Cedar Knolls
State: NJ



Job Summary:


Assures consistent quality of daily operations by enforcing laboratory protocols; evaluating SOP’s; reviewing quality control;
proficiency management; biannual assessment; competency of technical staff; performing corrective action as required;
inspection preparation as needed.

Quality Assurance Manager Job Duties:
  • Accomplishes quality assurance objectives by assigning, scheduling, assessing employees; communicating job expectations; planning, monitoring; reviewing job contributions; enforcing policies and procedures.
  • Achieves quality assurance operational objectives by contributing information and analysis; preparing and completing action plans; implementing quality standards; identifying and resolving problems; completing internal audits; recommending system improvements.
  • Meets quality assurance objectives by reviewing internal quality protocols and procedures and initiating corrective action as needed.
  • Develops quality assurance SOP’s, identifies preventive measures; monitors procedures and verifies/enforces procedures.
  • Validates quality processes by confirming CLSI guidelines are being followed, while documenting evidence determining operational and performance qualifications.
  • Maintains and improves laboratory quality by completing: LIS transmission verification, proficiency submission, biannual assessment, product recall attention, investigating customer complaints/concerns.
  • Collaborates with other members of management as needed in order to ensure consistent compliance with both state and federal guidelines.
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Performs routine laboratory protocol checks using internal audit procedures.

Requirements:


  • Ideal candidate will have 3 years previous Quality Assurance management experience in clinical laboratory operations.
  • Credentials associated with NY Generalist Supervisor.
  • In-depth knowledge of statistical analysis.
  • Experience in staff supervision.
  • In-depth knowledge of federal and state (NJ, NY) guidelines.
  • Ability to multi-task, working on multiple projects simultaneously.