DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Delivers quality customer service to all customers.
Develops and manages centralized review, approval and tracking of all BSI systems' user access and provides detailed access rights reports.
Ensures systems' security by conducting audits, monitoring reports and evaluating threats. Assists in the development, review and/or approval of internal audits, responses to internal and external citations, requests to FDA for variance, submission of SOPs for FDA review, and evaluation of non-conforming software applications as is relates to security and privacy.
Researches, prepares and writes security and privacy policies, SOPs, validation and implementation protocols that comply with regulatory, industry and BSI standards. As directed, monitors on-site evaluations and testing. Acts as a resource.
Researches, recommends and evaluates security and privacy products, devices and methodologies for BSI and vendors. Partners with the Information Technology Department on selection and implementation of computer security systems and tools. Evaluates software applications, as it relates to security privacy.
Configures software parameters to comply with business and regulatory security and privacy requirements.
Develops and/or delivers security and privacy training, as directed.
Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree in related area required.
Current understanding of HIPAA, FDA Part 11 and applicable federal and state security and privacy legislation required.
Current understanding of federal and AABB standards governing blood center-manufacturing activities preferred.
Security certification (e.g., GIAC, CISSP) in security management from a nationally recognized organization required.
Five years related experience required.
Blood banking or healthcare experience preferred.
Strong interpersonal, written and verbal communication skills. Ability to work independently and in a team environment.
Technical ability using security applications on networked systems in the areas of authentication, access control, encryption, electronic signature and Internet security.
Strong project management skills and problem solving skills.Proficient computer skills.
Employer Inc. is an equal opportunity employer.
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to or call to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
Please see the below information about applicant rights and our commitment to compliance:
EEO is the Law
EEO is the Law Supplement
All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.
Analyst, CISSP, Customer Service, Development, Encryption, FDA, Management, Project, Project Management, Protocols, Security, Supervision, Testing, Validation
Capital Markets Placement