Compliance Specialist (Technical Operations Specialist Iii)

Overview

At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

Responsibilities

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.

Qualifications

Education:

• Associate degree in a related field

Related Experience:

• A minimum of three (3) years of blood banking or related technical experience.

• 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.

Preferred Qualifications:

• Experience: Health care setting.

• Quality auditing experience preferred.

Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and expertise to perform the job's essential functions.

For applicants who will perform this position in New York City or Westchester County, the proposed hiring rate is $30.50 p/hr. . For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience.

Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.