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Quality Applications Specialist
Miami Lakes, Florida
Contract Position
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Applied on October 26, 2020
Job Id #43668 Posted October 9, 2020


Position Summary :

  • Managing Validation activities supporting the post market product analysis of a new product launch.
  • Validation activities will involve creation and documentation approval for various validation activities and planning out the project from start to finish.
  • Management of projects will involve teaming up with stack holders and coordinationing with programmers/developers and operating personnel, both domestic and global.
  • Must identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Will Report on the status of validation activities to fulfill regulatory requirements.

Responsibilities :

  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
  • Performs system administration and configuration of quality information technology systems. 
Organizational Impact:
  • Sets objectives for own job area to meet the objectives of projects and assignments.
  • Contributes to the completion of project milestones .
  • May have some involvement in cross functional assignments.
Innovation and Complexity:
  • Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
  • Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence:
  • Communicates primarily and frequently with internal contacts .
  • External interactions are less complex or problem solving in nature.
  • Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.
Leadership and Talent Management:
  • May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:
  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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