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Quality Assurance/Compliance Manager


Quality Assurance/Compliance Manager

Quality Assurance/Compliance Manager

Rhode Island Blood Center
Providence, RI 02908

Job details

Job Type

Full-time
Overview:
In 1979, the Rhode Island Blood Center was established by the hospitals in Rhode Island as a private, not for profit agency to collect, test, and distribute blood products. Today, the Rhode Blood Center is a division of New York Blood Center and is among the nation's premium providers of blood products and services and an integral part of the Rhode Island community's health care system. As of December 2018, the Rhode Island Blood Center employs approximately 320 full- and part-time employees. Our employees are committed to the Blood Center's mission of providing a safe and adequate blood for patients within our community. We seek individuals who are caring and compassionate, who take pride in their work, and are looking for a rewarding experience. At the Rhode Island Blood Center, you not only have a job but also the opportunity to make a difference.
Responsibilities:
This position reports to the VP, Quality. Ensures all regulated areas achieve and maintain compliance with the FDA, AABB, and any other accrediting agency that inspects and/or audits Rhode Island Blood Center. This position represents RIBC when communicating with regulatory agencies. The scope of this responsibility extends into all areas and systems that contribute to the quality of products and services provided by Rhode Island Blood Center.

This position serves as the administrator of the office of QA and software used to track quality indicators throughout the company. This position ensures all QA/C staff are trained to monitor and review regulatory documents and activities. This position must mentor QA/Compliance Specialist and other departmental staff in achieving quality outcomes in everyday activities.

  • Coordinates the implementation of NYBCe policy and practice standards and ensures RIBC is able to fulfill the requirements.
  • Researches regulatory requirements and coordinates RIBC’s required actions to comply with new guidance. Provides clear guidance to the departments prior to implementation of new activities or procedures.
  • Develops technical workshops or company training to ensure standardized methods and processes are followed when addressing quality and compliance procedures. Oversees the validation of QA software. Leads impact assessment meetings when discussing projects, process changes, validation and new regulations.
  • Reviews departmental QA activities on a quarterly basis to track and trend quality indicators submitted by departments. Compiles summary for Quality meetings. Identifies areas for improvement and works with the VP-Quality to address change.
  • Responsible for coordinating RIBC’s response to FDA, AABB and other regulatory agencies with regard to inquiries, citations or nonconformities.
  • Coordinates staff assignments and oversees internal audits, validations and other regulatory activities. Trains QA/Compliance staff.
  • Ensures the staff can provide accurate records before, during and after audits. Help QA/C staff to develop internal audits on a quarterly basis.
  • Ensures RIBC is able to utilize QA/C tools to track and trend QA activities. Follows up on items from internal audits to ensure complete, consistent, accurate and timely compliance with regulations.
  • Responsible for preparation of safety, exposure control and disaster preparedness plans for the company.
  • Remains current on industry trends and receives updates from regulatory agencies.
  • Coordinates company-wide required annual training programs (cGMP,GTP and Bloodborne Pathogen).
Qualifications:
Individual must have strong organization, interpersonal and communication skills, both verbal and written. Must be able to effectively and professionally interact and mentor all levels of employee. Individual must be self-directed and have the desire to own decisions and take responsibility for the outcome. Experience in healthcare setting, preferably on a supervisory level is required.

Bachelor’s degree required and MT(ASCP), BB(ASCP), or SBB(ASCP) certification required. Significant experience in a related field in lieu of educational and certification requirements will be taken into consideration.

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• Location: NA

• Post ID: 21416743


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