Senior Quality Assurance Specialist - Operations

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care

If you're a QA expert when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Sr. Quality Assurance Specialist with a background in blood banking, medical device, and/or the pharmaceutical industry. This critical role is responsible for providing quality oversight at the shop floor level to address immediate quality issues. If you've got the necessary skills and experience to excel in this role, we want to hear from you!

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)

Key Accountabilities

• Working with manufacturing operations to solve in-house quality concerns as well as reviewing nonconforming product and recommending disposition
• Working with employees to identify and develop continuous improvement strategies that will drive operational excellence and increased capacity and cost reductions
• Conducting assessments of manufacturing operations to provide focused quality improvement opportunities
• Collecting, sorting and reporting data on operations quality performance metrics as well as providing trend analysis of defects occurring at the shop floor
• Devising sampling procedures and designing and developing forms and instructions for recording, evaluating, and reporting data
• Developing and implementing a shop floor self-audit program, including sharing of findings and determination of proper corrective and preventive actions
• Leading cross-functional teams to implement continuous improvements, 5S, standard work, s value stream mapping exercises, and visual standards
• Participating in CAPA Review Board, Change Orders meetings and other critical decision-making meetings as required to define and assess impact at the shop floor
• Managing the Suppliers Quality Agreements Program
• Working with Research & Development in the verification, validation and transfer of Software/Systems and Assay programs
• Assisting Operations with process validation and equipment/facility qualification for implementation into production
• Representing the Sr. Quality Director and Operations Managers in a variety of forums

Minimum Knowledge & Experience required for the position:

• Bachelor's degree in Life Sciences / Engineering or other science related or technical field, required
• 7-10 years of current experience in Blood Banking, Medical Device, and/or Pharmaceutical industry
• 5+ years in QA function with relevant experience executing, developing and/or administrating cGMP quality programs
• Knowledge of cGMP
• Frequent computer/report work, and administration of quality system programs and resources
• Demonstrated problem solving and root cause analysis skills
• ASQ Certified Quality Auditor (CQA) / Certified Quality Engineer (CQE), preferred
• Experience with Trackwise data management system, preferred

Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com