Specialist III -Technical Operations

New York Blood Center Inc•City of 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. It supports the development, writing, and execution of validation test cases according to NYBCe guidelines, coordinating activity with QRA and Information Technology. The role collaborates with the QA/Compliance, IT, and Collections management team regarding BECS, change control, and validation activities. The Specialist III must remain current in knowledge of guidelines and developments within the regulatory environment. This role provides support of software applications to Collections Operations in Mobile and Donor Center locations, resolving complex problems and issues relating to technology, and tracking events as appropriate, forwarding to Information Technology as applicable. The Specialist III generates and resolves deviations for the Collections Operation team and completes deviations and CAPA analysis in Quality Management Software, identifying trends to recommend positive changes to improve all processes. They develop and maintain Standard Operating Procedures (SOPs) while ensuring regulatory compliance. The Specialist III collaborates with Collections management on quality indicators, error management statistics, audits, and CAPA investigations. They assist with the maintenance, review, and follow-up of all activities with the Collections Department, including all document control activities. The role performs QC activities, monitors equipment maintenance, and ensures required recordkeeping and compliance with all regulations and standards. The Specialist III assists Donor Service Management in completing quality audits to ensure operations comply with all regulations, standards, policies, and procedures. This role provides counsel to donors who have experienced adverse events resulting from donation events and initiates the required process for incidents indicative of a potential legal claim. They serve as a liaison between donors and the Medical Director/designee regarding positive test results and donor re-entry. The Specialist III provides donation eligibility guidance to Collection Staff, advises donors regarding donation eligibility status, and ensures appropriate entry of donor deferral status into the BECS system. They coordinate document control activities for fixed and mobile operations and facilitate the implementation of procedures to ensure timely switch out of SOPs, forms, job aids, training materials, and applicable resources. The Specialist III maintains the skillset for activities performed by the Technical Specialist II position, which includes reviewing donor medical screening and analyzing against standards and procedures to confirm donor eligibility for all procedure types. This includes reviewing and reconciling donor records and records generated during the donor procedure to support traceability in blood donations and to release units, which may result in the discard of the product. Deviations are generated in the Quality Management System as appropriate. The Specialist III provides 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. They identify errors and correct information regarding deferrals in the system, communicating errors, and accessing appropriate data and systems. The Specialist III audits apheresis collections and ancillary documents to ensure product conformance and that extended testing is processed per SOP. They identify possible duplicate donors and perform investigations to resolve them, which may involve the use of tools such as PeopleFinder or Accurint. Deviations are initiated when discrepancies with product consequences, current or past, are identified. The Specialist III performs lot release based on total quality control and review of donor records. For applicable post-donation information, the Specialist III follows up on information received from the donor, reviews past donations to correlate donor responses, generates deviations when necessary, and applies product holds. The Specialist III maintains all collections competency if promoted from Collections Operations, prepares various reports, attends conferences and seminars as required, makes recommendations to improve business unit practices and processes, and performs 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.
Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
Ability to problem solve customer issues.
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

Maintains a high knowledge of the collections process, including validation and compliance initiatives.
Manages all document control functions for collections.
Supports the development, writing, and execution of validation test cases according to NYBCe guidelines, coordinating activity with QRA and Information Technology.
Collaborates with the QA/Compliance, IT, and Collections management team regarding BECS, change control, and validation activities.
Remains current in knowledge of guidelines and developments within the regulatory environment.
Provides support of software applications to Collections Operations in Mobile and Donor Center locations.
Resolves complex problems and issues relating to technology.
Tracks events as appropriate, forwarding to Information Technology as applicable.
Generates and resolves 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.
Collaborates with Collections management on quality indicators, error management statistics, audits, and CAPA investigations.
Assists with maintenance, review, and follow-up of all activities with the Collections Department, including all document control activities.
Performs QC activities, monitors equipment maintenance, and ensures required recordkeeping and compliance with all regulations and standards.
Assists Donor Service Management in completing quality audits to ensure operations comply with all regulations, standards, policies, and procedures.
Provides counsel to donors who have experienced adverse events resulting from donation events and initiates the required process for incidents indicative of a potential legal claim.
Serves as a liaison between donors and the Medical Director/designee regarding positive test results and donor re-entry.
Provides donation eligibility guidance to Collection Staff.
Advises donors regarding donation eligibility status and ensures appropriate entry of donor deferral status into the BECS system.
Coordinates document control activities for fixed and mobile operations.
Facilitates implementation of procedures to ensure timely switch out of SOPs, forms, job aids, training materials, and applicable resources.
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.
Generates deviations in the Quality Management System as appropriate.
Provides 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.
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.
Follows up on post-donation information as received from the donor.
Reviews past donations to correlate donor responses.
Generates deviations when necessary and applies product holds.
Maintains all collections competency if promoted from Collections Operations.
Prepares various reports.
Attends conferences and seminars, as required.
Makes recommendations to improve business unit practices and processes.
Performs any related duties as assigned.