Sr. Quality Assurance Specialist, Blood Products

Date: Sep 9, 2024

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel : None

Requisition ID :10866

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 .

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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 minimal consultation with Quality management. This individual will independently review and approve Blood Product documents to ensure the blood product's identity, safety, quality, and purity. The individual will monitor production and laboratory operations to ensure compliance with cGMPs and Blood Product procedures. The individual will support project activities, product disposition, product complaints, supplier management, training, change management, field alerts/biological product deviation Reporting/Recalls, and other quality activities related 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 with 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 approves change orders, investigations, non-conforming events, CAPAs, and other associated activities.

• Support the supplier management program. Maintain Supplier Approval List and issue supplier corrective actions reports as needed.

• Develop and ensure execution of internal and external audit schedules related to Blood Products.

• 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 internal and external stakeholders to ensure communication of outcomes.

• Participate in on-site Regulatory Inspections.

• Provide metrics and data-driven solutions to reduce the 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 in biology, chemistry, or engineering preferred with 7 years of relevant in quality and/or related manufacturing engineering experience in manufacturing site required.

• Facilitate the timely change, approval, and release of change orders per respective system requirements (PLM, ERP)

• Independently perform quality reviews and approve change orders, investigations, non-conforming events, CAPAs, and other associated activities

• Ensure procedures are in place to classify and maintain appropriate records across all areas of the Quality System

• Problem-solving and quality improvement, including quantitative methods.

• Validations (product and process IQ/OQ/PQ).

• Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques).

Specialized Skills / Other Requirements

• Excellent written and oral communication skills

• Working knowledge of quality systems and compliance in a regulated industry

• Advanced database skills and experience with PLM and ERP software

• Ability to effectively execute projects and related activities with appropriate priority required

• Good understanding of Pharmaceutical and Biologics cGMPs (21 CFR 210 - 211 and 600 - 640)

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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.

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