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MD Anderson Cancer Center Clinical Laboratory Coordinator - Deviation Program Management in Houston, Texas

JOB SPECIFIC COMPETENCIES

Deviation Program Management.

-Ensures timely product/risk containment, investigation, follow-up and reporting of deviations.

-Ensures all deviations are detected, assessed, corrected and CAPA implemented if applicable.

-Oversee all process improvement project to completion.

-Tracks deviations for trends

-Completes all appropriate documentation involved in the investigation

-Collaborate with legal on the appropriate follow-up.

-Initiates appropriate accreditation notification e.g. FDA, AABB within the requirement timeline.

-Classify deviation according to the FDA's Biological Product Deviation Report (BPDR)

-Track and trend deviations -Report deviations tracking and trending summaries to MD Anderson Leadership

-Collaborates with Transfusion Medicine Leadership to develop process improvement plans.

Ensures regulatory preparedness at all times.

  • Ensures competency assessments are completed according to guidelines.

  • Ensures compliance with all regulatory and safety standards and enforces policies and procedures.

  • Documents receipt, routing, and completion of CAP proficiency testing and follows up with supervisors on any unacceptable results for corrective actions and reply to CAP.

  • Maintain procedure manuals, education records, quality and all CAP and CLIA standards.

  • Serve as a technical resource for staff and internal customers.

Ensures laboratory meets quality and productivity standards.

  • Ensures adequate quality control methods are implemented according to standard and addresses quality control issues.

  • Is a subject matter expert.

  • Ensures supplies and equipment are ordered and maintained to meet laboratory needs.

  • Assists with data base testing and recommends modification to the database.

  • Ensures productivity is sufficient to meet time constraints established for current procedures and processes.

  • Continually explores process improvement and efficient operation opportunities.

  • Perform clinical lab assays, tests, and procedures as appropriate.

  • Coordinate new test/protocol development and oversee the development and maintenance of new policies and procedure documents.

  • Responds to the section's needs by meticulously reviewing, interpreting and assistance in writing reports for pathologist review and sign-out demonstrating accuracy and a high standard of quality.

Manages customer service interactions and relationships with diplomacy and professionalism.

  • Initiate, develop, and manage relationships and networks

  • Show sincere interest in others and their concerns. Listen to feedback and input in a professional manner,

  • Demonstrate attention to others

  • Acknowledges and listens to differing perspectives in a group. Performs personnel supervision duties including, but not limited to, counseling supervisors or techs, monitoring Techs PDM progress, competency assessments, and orientations. Assists in oversight with the development of new tests, procedures, or instrumentation

Bachelor's degree in Medical Technology, Clinical Laboratory Science, Molecular Genetic Technology or a related science field (Biology, Chemistry, Physiology). Eight years of experience in a clinical laboratory to include three years of lead or supervisory experience. One of the following: Technologist/Scientist certification in Blood Banking (BB), Chemistry (C), Cytogenetics (CG), Histology (HT), Hematology (H), Histotechnologist (HTL), Microbiology (M), Medical Laboratory Scientist (MLS) or Molecular Biology (MB) by the American Society of Clinical Pathologists (ASCP) Board of Registry (BOR) OR Certified Histocompatability Technologist by the American Society of Histocompatability and Immunogenetics (ASHI) OR Medical Technologist (MT) or Molecular Diagnostics Technologist (MDT) by the American Medical Technologists (AMT). It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

  • Requisition ID: 152269

  • Employment Status: Full-Time

  • Employee Status: Regular

  • FLSA: exempt and not eligible for overtime pay

  • Work Week: Days

  • Fund Type: Hard

  • Work Location: Onsite

  • Pivotal Position: Yes

  • Minimum Salary: US Dollar (USD) 82,000

  • Midpoint Salary: US Dollar (USD) 102,500

  • Maximum Salary : US Dollar (USD) 123,000

  • Science Jobs: No

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