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Werfen Immunoassay • San Diego, California, United States
Salary: $22 - $30 / hour
Role & seniority: Quality Engineering Intern (internship for students; entry-level supportive role within Werfen’s Quality Engineering team)
Stack/tools: quality system documentation; statistics-based quality activities (capability studies, gage R&R, test method validation, acceptance sampling); process/product development; risk assessments; verification/validation; knowledge of cGMP and GDP preferred
Write quality system documents compliant with regulations and standards
Participate in process validation teams and support cross-functional problem solving for product/process quality issues
Conduct risk and trend evaluations for non-conformances; help identify root cause and implement corrective actions
Currently enrolled in bachelor’s or graduate program; GPA ≥ 3.0
Strong written and verbal communication
Basic understanding of quality engineering principles and metrology; familiarity with cGMP/GDP preferred
Experience with root cause investigation, CAPA, and statistical techniques
Exposure to quality systems, verification/validation activities, and regulatory standards
Location & work type: Internship role; location not specified (Werfen operates globally with HQ in US/Europe); full-time work type aligned to internship program
Werfen
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.
Overview
Overview
The Internship program has been designed to allow students to learn through hands-on experience, providing an opportunity to blend textbook knowledge with practical experience. The Quality Engineering Intern works with Werfen’s Quality Engineering team in a wide range of quality-related engineering activities including, but not limited to, process development, product development, root cause investigation, risk assessments, verification/validation, continuous improvement projects and be a key resource for the proper use of statistics including capability studies, gage R&R, test method validation and acceptance sampling plans.
Responsibilities
Key Accountabilities
Write quality system documents that comply with applicable regulations and standards Participate in process validation teams Work cross-functionally, as a key resource, to solve problems related to product or
process quality issues; investigate non-conformances, identify root cause, and
determine/implement appropriate corrective action plans
Conduct risk and trend evaluations for product non-conformances Ability to prioritize urgent matters Other duties as assigned
Qualifications
Currently enrolled in a bachelor’s or graduate degree program with a minimum GPA of 3.0.
Skills And Capabilities
Excellent written and verbal communication skills are required. Basic understanding of quality engineering principles including root cause investigation, is desired. Basic understanding of current Good Manufacturing Practices (cGMP) & Good Documentation Practices (GDP) is desired. Basic understanding of metrology principles is desired.
Acknowledgement
The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. I have read and understand the job description for my position. I agree to comply with the corporate compliance policy and all laws, rules, regulations and standards of conduct relating to my position. I understand that this does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of my employment with Werfen.
The hourly range for this role is $22/hr to $30/hr. Individual compensation will ultimately depend on factors including relevant experience and grade level completed.
Closing
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.