Job Description Summary
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. bd.com
Job Description
The Quality Assurance Specialist is primarily responsible for executing the planning, development, and implementation of training strategy for the BOC associates and general compliance related activities at the office, as developed/co-developed by the BOC QA Director. The QA Specialist will also be responsible for the documentation and record retention processes at the BOC and the management of the internal audits and CAPA records.
Supports general BOC Quality Assurance activities within the department.
Develops/Co-Develops and maintains training matrix aligned with QMS (Quality Management System) requirements.
Direct responsibility for monitoring of training database, as applicable.
Liaise with other functional/departmental managers to intake all necessary requirements to ensure proper application of associate training and verification of effectiveness.
Monitors, measures and reports on associate training and development plans and achievements within agreed formats and timescales.
Oversight of new hire training programs with responsibility for ensuring the learning path is completed as established.
Work with third party internal and external stakeholders to ensure training compliance, and objectives are being managed appropriately.
Prepares various training materials and coordinate schedules in advance due to changes in current practices and/or procedures.
Responsible for records retention and administrator for Quality System database (i.e. Master Control) for the BOC Office.
Analyzes data and prepares reports for Management Review Mtgs, Weekly / Monthly Reports and others as necessary.
Responsible for uploading, and custody of, related Guardrails documentation.
Support/participate on Internal, External, Third Party and/or regulatory agency audit activities and the corresponding audit actions that may result from them.
Support/participate in the CAPA process. May perform CAPAs or evaluate CAPA files.
Assures is trained before performing any task.
Uses the required clothes, personal and security protective equipment according to the requirements of its operation.
Complies with the cGMP’s, Quality Standards and established policies and/or procedures.
Executes other duties assigned by supervisor.
Education and/ or Experience Required:
Bachelor’s Degree
One (1) to Three (3) years of experience as Training Specialist or equivalent position in a regulated environment
Basic knowledge of compliance and Quality Systems
Additional Desirable Qualifications Skills and Knowledge:
Must be bilingual (English/ Spanish) and must have good communication skills both oral and written
Teamwork oriented
Proficient on MS Office (Excel, Word, Power Point)
Must be able to interact with different kinds of people in a harmonious manner, being cognizant of basic corporate, plant and department goals.
Strong organizational skills
Professionalism
Problem Solving
Primary Work Location
USA PR - Guaynabo
Additional Locations
Work Shift
US BD 1st Shift 8am-5pm (United States of America)
