Specialist III -Technical Operations

New York Blood Center Enterprises•Rye, NY

3d•Onsite

About The Position

This position maintains a high knowledge of the collections process, which may include validation and compliance initiatives, in addition to managing all document control functions for collections. Supports the development, writing, and execution of validation test cases NYBCe guidelines, coordinating activity with QRA and Information Technology. Collaborate with the QA/Compliance, IT, and Collections management team regarding BECS, change control, and validation activities. Remain current in knowledge of guidelines and developments within the regulatory. Provide support of software applications to Collections Operations in Mobile and Donor Center locations. Resolve complex problems and issues relating to technology. Tracking events as appropriate, forwarding to Information Technology as applicable. Generate and resolve deviations for the Collections Operation team. Completes deviations and CAPA analysis in Quality Management Software, identifying trends to recommend positive changes to improve all processes. Develops and maintains Standard Operating Procedures (SOPs) while ensuring regulatory compliance. Collaborate with Collections management on quality indicators, error management statistics, audits, and CAPA investigations. Assist with maintenance, review, and follow-up of all activities with the Collections Department, including all document control activities. Perform QC activities, monitor equipment maintenance, and ensure required recordkeeping and compliance with all regulations and standards. Assist Donor Service Management in completing quality audits to ensure operations comply with all regulations, standards, policies, and procedures. Provide counsel to donors who have experienced adverse events resulting from donation events and initiate the required process for incidents indicative of a potential legal claim. Serve as a liaison between donors and the Medical Director/designee regarding positive test results and donor re-entry. Provide donation eligibility guidance to Collection Staff. Advise donors regarding donation eligibility status and ensure appropriate entry of donor deferral status into the BECS system. Coordinate document control activities for fixed and mobile operations. Facilitate implementation of procedures to ensure timely switch out of SOPs, forms, job aids, training materials, and applicable resources. Maintains skillset for activities performed by Technical Specialist II position: Reviews donor medical screening and analyzes against standards and procedures to confirm donor eligibility for all procedure types. Reviews and reconciles donor records and records generated during the donor procedure to support traceability in blood donations and to release units. The review may result in the discard of the product. Generates deviations in the Quality Management System as appropriate. Provide the Medical Director with information to resolve complex donor eligibility issues. Ensures the donor is notified of the outcome and notifies Collections management when changes are required and/or when medical eligibility issues are resolved. Identifies errors and corrects information regarding deferrals in the system, communicating errors, and accessing appropriate data and systems. Audits apheresis collections and ancillary documents to ensure product conformance and that extended testing is processed per SOP. Identifies possible duplicate donors and performs investigation to resolve. This may involve the use of tools such as PeopleFinder or Accurint. Initiates deviation when discrepancies that have product consequences, current or past, are identified. Performs lot release based on total quality control and review of donor records. Post Donation Information (as applicable): Follows up on post-donation information as received from the donor. Review past donations to correlate donor responses. Generates deviations when necessary and applies product holds. Maintain all collections competency if promoted from Collections Operations. Prepare various reports. Attends conferences and seminars, as required. Makes recommendations to improve business unit practices and processes. Any related duties as assigned.

Requirements

Associate degree in a related field.
A minimum of three (3) years of blood banking or related technical experience.
Knowledge of documentation practices and procedures.
Knowledge of AABB, FDA and OSHA regulations.
Working knowledge of Microsoft Suites.
Knowledge of validation processes, software, and equipment.
Diligence and organizational skills.
Meticulous attention to detail.
Cultural competency and the ability to communicate effectively in a culturally sensitive manner with diverse individuals and groups.
Ability to problem solve customer issues.
Ability to maintain composure under pressure.
Ability to collaborate with a team in a fast-paced, ever-changing environment.
Ability to resolve problems.
Ability to create analysis on a variety of facilities, process information and identify trends, patterns, and deficiencies and follow-up where needed.
Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the job's essential functions.

Responsibilities

Maintain a high knowledge of the collections process, including validation and compliance initiatives.
Manage all document control functions for collections.
Support the development, writing, and execution of validation test cases for NYBCe guidelines.
Coordinate validation activities with QRA and Information Technology.
Collaborate with QA/Compliance, IT, and Collections management on BECS, change control, and validation.
Stay current with guidelines and developments within the regulatory environment.
Provide support for software applications in Collections Operations (Mobile and Donor Center locations).
Resolve complex problems and issues related to technology.
Track events and forward them to Information Technology as applicable.
Generate and resolve deviations for the Collections Operation team.
Complete deviations and CAPA analysis in Quality Management Software, identifying trends for process improvement.
Develop and maintain Standard Operating Procedures (SOPs) ensuring regulatory compliance.
Collaborate with Collections management on quality indicators, error management statistics, audits, and CAPA investigations.
Assist with the maintenance, review, and follow-up of all activities within the Collections Department, including document control.
Perform QC activities, monitor equipment maintenance, and ensure recordkeeping and compliance with regulations.
Assist Donor Service Management in completing quality audits.
Provide counsel to donors who have experienced adverse events and initiate processes for potential legal claims.
Serve as a liaison between donors and the Medical Director/designee regarding positive test results and donor re-entry.
Provide donation eligibility guidance to Collection Staff.
Advise donors on donation eligibility status and ensure correct entry into the BECS system.
Coordinate document control activities for fixed and mobile operations.
Facilitate implementation of procedures for timely updates of SOPs, forms, job aids, and training materials.
Review donor medical screening and analyze against standards to confirm donor eligibility.
Review and reconcile donor records to support traceability and release units.
Generate deviations in the Quality Management System as appropriate.
Provide information to the Medical Director to resolve complex donor eligibility issues.
Ensure donor notification of outcomes and inform Collections management of necessary changes or resolved issues.
Identify and correct errors in deferral information, communicating errors and accessing appropriate data.
Audit apheresis collections and ancillary documents for product conformance and extended testing.
Identify possible duplicate donors and perform investigations.
Initiate deviations for discrepancies with product consequences.
Perform lot release based on quality control and review of donor records.
Follow up on post-donation information, review past donations, and generate deviations when necessary.
Apply product holds when necessary.
Maintain collections competency.
Prepare various reports.
Attend conferences and seminars as required.
Make recommendations to improve business unit practices and processes.