Job Information
About the Position
Introduction
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
Position Summary:
Responsible for the technical analysis of raw materials, in-process and finished products, product failures and complaints; support and/or technical support of validations; verification of product claims and dating: and/or provides technical support for formulation and QC testing. Supervises staff as needed.
Responsibilities
Key Accountabilities:
- Coordinates studies which are appropriate for validation, process improvement, product failure or complaint.
- Performs automated and manual processes/assays per organization Standard Operating Procedures (SOP), Standard Production Method (SPM) or Quality Control Monographs (QCM)
- Develops and recommends revisions and improvements to production and quality system documentation.
- Participates in project teams as directed.
- Responsible for coordinating and performing preventive maintenance, troubleshooting, cleanliness and calibration of laboratory equipment. Ensures that appropriate records are maintained
- Assures as necessary that Statistical Process Control records are maintained
- Prepares Change Orders, Condition for Release, and Incident Reports, etc. as required
- Sets a personal example of behavior and commitment to company values and plant objectives to encourage a high level of morale and teamwork for all employees
- Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department performance.
- Performs all work within organization according to organizational policies, GMP, and ISO Standards
- Performs other duties and responsibilities as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions
Networking/Key Relationships:
- To be determined based on department needs
Skills & Capabilities:
- Functional/technical skills
- Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP)
- Demonstrated ability to organize work assignments
- Knowledge of laboratory equipment/QC instruments
- Proficiency in common laboratory techniques
- Oral and written communication skills
- Business acumen, timely decision making
Qualifications
Minimum Knowledge & Experience Required for the Position:
- Requires BS in a Science or Medical Technology or equivalent, plus minimum four years of experience of clinical laboratory or formulation.
- Supervisory experience preferred.
Travel Requirements:
- <5% of time
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