Medical Laboratory Technologist II, Technical Specialist
4 weeks ago
Medical Laboratory Technologist II, Technical Specialist
Job Locations
US-GA-Norcross
Job ID
2024-3541
Category
Quality
Overview
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.
We are seeking a Medical Laboratory Technologist II, Technical Specialist to join our Quality Laboratory team. The Medical Laboratory Technologist II, Technical Specialist is responsible for performing a variety of tasks and functions associated with the appropriate day-to-day operations of the Technical Specialist division within the Quality Laboratories. As a Medical Laboratory Technologist II, Technical Specialist, you will 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 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.
This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.
Medical Laboratory Technologist II, Technical Specialist - Quality Laboratory
ResponsibilitiesKey Accountabilities:
- Serves as Medical Technologist Technical Specialist to ensure the alignment of the labs with qualification of antisera
- Technical writer for SOPs, OJTs and documentation of training metrics for lab services
- Performs administrative tasks and duties, when applicable; including the required recording of test results according to department procedures, quality plans/device history records, and/or work instructions (manufacturing records) and assisting with review of generated records
- Participates in the internal audit process. Assists with special projects, (such as Surveys and Validations)
- Performs Antisera Qualification duties as needed
- Performs department Technical Review of documents prepared in the laboratory
- Assists with training of identified trainers in each laboratory
- Assists in training, retraining, and competency assessment of employees
- 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 non-conformance
- 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
- Able to work cross-functionally across departments
- Ensure adequate communication with Managers or staff (verbally or written)
- Support implementation of metrics and drive the performance of the metrics
- Participate in the SOP review and revision process
Medical Laboratory Technologist II, Technical Specialist - Quality Laboratory
QualificationsMinimum Knowledge & Experience required for the position:
- Bachelor's Degree in Medical Technology, Life Sciences or other science or technical field
- MT(ASCP) or equivalent certification (preferred)
- 1-3 years of experience in Blood Banking
- 1+ years of experience in a highly Regulated/GMP environment
- Strong mathematical, analytical and problem solving skills
- Excellent communication skills both written and verbal
- Ability to work second shift 1pm-9:30pm, Monday to Friday
Medical Laboratory Technologist II, Technical Specialist - Quality Laboratory
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
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