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Quality Systems Specialist 1 Jobs

Company

LifeLink Foundation, Inc.
Address , Tampa, 33619, Fl
Employment type FULL_TIME
Salary
Expires 2023-07-23
Posted at 11 months ago
Job Description

Summary:

Responsible for supporting all change management activities at LifeLink Tissue Bank to include Change Events, Planned Deviations, and some Document Management functions. Responsible for supporting the initial evaluation and triage of Change Event Requests and Planned Deviation Requests as well as participating in the maintenance of the digital document management system.

Responsibilities:

  • Serves as the primary responsible individual for the evaluation of potential impact to LLTB quality systems triggered by Change Events and Planned Deviations. This includes performing and documenting decisions regarding impact to other systems and departments, developing change event plans, review completed deliverables against plans, and archiving all records associated with Change Events and Planned Deviations.
  • Serves as the secondary responsible individual for all aspects of the document change process, including obtaining approval on document changes, implementing document changes, distributing documents, archiving documents, and annual document review, which includes converting document formatting and organization of information across document families.
  • Supports the Quality Assurance team in preparing responses for qualification surveys of LifeLink Tissue Bank.
  • Responsible for contributing to continuous improvement projects related to their scope of authority, as directed.
  • Responsible for contributing to the development of training content as it pertains to systems within their scope of authority.
  • Maintain current knowledge of quality and tissue banking best practices and evolving industry trends and requirements.
  • Ensures compliance to AATB standards, FDA, applicable state, and international regulations within their scope of authority.
  • Ensures the establishment, maintenance, and communication of key performance indicators pertinent to monitoring the health of systems within their scope of authority.

Requirements:

  • Requires experience managing and working closely with controlled documents within a document control system in a regulated industry (e.g., drug, medical device, tissue, aviation, food, etc.).
  • Requires experience in participating in supporting complex quality systems and quality audits.
  • Requires proficiency with Microsoft Office365 (Word, Excel, PowerPoint, Teams, SharePoint) and Adobe Acrobat.
  • Requires a bachelor’s degree in business, technical writing, healthcare, or related field.
  • Requires interpersonal ability to effectively interact with management and staff.
  • Requires excellent verbal and written communication.
  • Requires excellent organizational skills, ability to manage competing priorities, and the ability to maintain a high-level of accuracy.
  • Requires working knowledge of all standards outlined by the LifeLink Tissue Bank SOPM and The American Association of Tissue Banks.
  • Certification by the American Society for Quality is preferred.
  • Requires experience in maintaining Current Good Documentation Practices, Current Good Tissue Practices, and working knowledge of data integrity (e.g. 21 CFR Part 11 compliance).
  • Requires working knowledge of the principles, practices, and tools related to Total Quality Management.
  • Demonstrated physical ability to lift, carry and/or move equipment and supplies of varying weight up to 15 pounds.

Working Conditions:

Work requires extended hours during peak processing and/or procurement periods. Office space and equipment will be provided to perform necessary duties.

OSHA Risk Classification: Low


Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.


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