Job Information
About the Position
Introduction
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
The Laboratory Services Superisor performs a variety of tasks and functions associated with the appropriate day-to-day operations of the Quality Laboratories and supervises the performance of a variety of tasks within the division.
Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. Serve as main point of contact for Laboratory Services. This includes but is not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, serological duties, chemistries and any other task associated with making sure the products reach the customers. Assist with review and approving of test data, preparing validation documents, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects.
Responsibilities
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Qualifications
Minimum Knowledge & Experience:
- Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience. Bachelor’s degree in Science discipline, required
- MT (ASCP) or equivalent, prefer SBB certification
- 5-7 years of experience in Blood Banking, preferred
- 3 years of experience in a highly regulated/GMP environment, preferred
- Lean Six Sigma and/or continuous improvement experience, preferred
- Ability to read, analyza and interpret the most complex documents. Ability to respond effectively to the highest level of inquires or complaints. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests relialibility and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
Skills & Capabilities:
- Creates legible, complete, and accurate records according to procedure/work- instruction-defined protocols, time frames and according to Current Good Manufacturing Procedures (cGMP’s).
- Follows applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Chemical hazards and blood borne pathogens), applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, etc.
- Understands FDA and ISO standards applicable to the department and consequences of nonconformance.
- Understands source, composition and characteristics of products and associated chemical and biosafety hazards.
- Maintains a polite, helpful, and professional manner with employees within the department and outside of the department.
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
