Sr. QA Specialist, Blood Products

Date: Mar 23, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3609

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Senior QA Specialist will have a good understanding of GMP regulations and be able to identify and resolve quality issues with 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 production and laboratory operations to ensure compliance to cGMPs and Blood Product procedures.  Senior QA Specialist provides direct oversight of the Supplier Management program.  The individual will support project activities, product disposition, product complaints, Field Alerts/Biological Product Deviation Reporting/Recalls 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 production and laboratory operations to ensure compliance to cGMPs and Blood Product procedures 
•    Independently 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  
•    Independently performs Quality review and approve change orders, investigations, non-conrfoming events, CAPAs and other associated activities
•    Provide direct oversight to the Supplier Management Program
•    Develop and ensure execution of internal and external audit schedules related to Blood Products
•    Maintain Supplier Approval List and issue supplier corrective actions reports as needed
•    Identifies and resolves quality issues using problem-solving skills, in consultation with management and other cross functional departments.
•    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 director 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 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
•    Seven 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 
 

 

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: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Minneapolis