QA Specialist, Blood Products (Lab)
Date: Dec 4, 2024
Location: Maple Grove, MN, US
Company: Teleflex
Expected Travel: None
Requisition ID: 11296
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Anesthesia and Emergency Medicine - At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. We equip clinicians with some of the most advanced medical devices on the market today, from our world-class brands including:
- LMA® and Rüsch® airway management devices designed to help reduce the risk of airway-related complications.
- Arrow pain management products designed to improve patients' post-operative pain experience.
- The Arrow® EZ-IO® System that helps address the time-critical challenge of emergency vascular access, and
- QuikClot® and QuickClot Control+® hemostatic devices, used by hospitals, EMS, and the military for hemorrhage control in a broad range of bleeding situations.
Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives.
Position Summary
QA Specialist will have a good understanding of GMP regulations and be able to identify and resolve quality issues with minimal consultation with Quality management. This individual will independently review and approve Blood Product documents to assure identity, safety, quality, and purity of the blood product. The individual will monitor laboratory operations to ensure compliance to GLP, cGMPs and Blood Product procedures. The individual will support incoming inspection activities, product disposition, change management, and other quality activities as they relate to Blood Products. The individual maintains, coordinates, monitors effectiveness and continually improves quality activities/programs related to blood products.
Principal Responsibilities
• Maintain and support required quality activities and programs for Blood Products.
• Monitor laboratory operations to ensure compliance to cGMPs and Blood Product procedures.
• Performs quality review and approval of Blood Product documents, such as Policies, Standard Operating Procedures, Work Instructions, Procedures, Plans, Study Protocols/Reports, Specifications and Forms.
• Performs quality review and approve change orders, investigations, non-conrfoming events, CAPAs and other associated activities.
• Support the incoming inspection program. Determine component disposition based on inspection procedures.
• Identifies and resolves quality issues using problem-solving skills, in consultation with management and other cross functional departments, as needed.
• Create and revise QMS procedures as needed.
• Create and lead Blood Products Quality Management System training.
• Identify and implement changes to the Blood Products Quality programs to improve effectiveness and efficiency.
• Communicates with management and other stakeholders, internal and external, to ensure communication of outcomes.
• Participate in on-site Regulatory Inspections.
• Provide metrics and data driven solutions to reduce cost of poor quality and improve monitoring system efficiency for blood products.
• Assists with Annual Product Review activities, complaint investigations, field alerts/biological product deviation reports and recalls as needed.
• Aid in evaluating and trending Blood Product QMS activities/programs for Management Review.
• Aid in assuring appropriate document management and product disposition.
Education / Experience Requirements
• Bachelor’s Degree preferred
• Three years of relevant experience required
Specialized Skills / Other Requirements
• Proficiency with MS Office programs
• Good organizational skills required
• Good understanding of Pharmaceutical and Biologics cGMPs (21 CFR 210-211 and 600-640)
• Good understanding of FDA Guidances for Industry
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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2024 Teleflex Incorporated. All rights reserved.