Technical Operations Specialist III

Blood Bank Of Delmarva - Newark, DE

Full-time - Mid Level

Newark, DE

101-250 employees

Ambulatory Health Care Services

About the position

The Technical Operations Specialist III at the Blood Bank of Delmarva plays a crucial role in maintaining compliance and operational efficiency within the blood collection process. This position involves managing document control functions, supporting validation initiatives, and collaborating with various teams to ensure adherence to regulatory standards. The specialist will also provide technical support for software applications used in collections and assist in quality audits and donor eligibility assessments.

Responsibilities

• Supports the development, writing, and execution of validation test cases according to NYBCe guidelines.
• Collaborates with QA/Compliance, IT, and Collections management regarding BECS, change control, and validation activities.
• Remains current in knowledge of guidelines and developments within the regulatory framework.
• Provides support of software applications to Collections Operations in Mobile and Donor Center locations.
• Resolves complex problems and issues relating to technology.
• Tracks events and forwards 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.
• 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 document control activities.
• Performs QC activities, monitors equipment maintenance, and ensures compliance with regulations and standards.
• Assists Donor Service Management in completing quality audits to ensure compliance with regulations, standards, policies, and procedures.
• Provides counsel to donors who have experienced adverse events and initiates required processes for incidents indicative of potential legal claims.
• Serves as a liaison between donors and the Medical Director regarding positive test results and donor re-entry.
• Provides donation eligibility guidance to Collection Staff and advises donors on eligibility status.
• Coordinates document control activities for fixed and mobile operations.
• Facilitates implementation of procedures for timely updates of SOPs, forms, job aids, and training materials.
• Maintains skillset for activities performed by Technical Specialist II position.
• Reviews donor medical screening and analyzes against standards to confirm donor eligibility.
• Audits apheresis collections and ancillary documents to ensure product conformance and extended testing processing per SOP.
• Identifies possible duplicate donors and performs investigations to resolve discrepancies.

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.

Nice-to-haves

• Experience in a health care setting.
• Quality auditing experience preferred.

Benefits

• Health insurance coverage.
• Paid time off.
• Professional development opportunities.