Technical Specialist- Evening Shift - Immucor, Inc.
Norcross, GA
About the Job
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.
Ability to work Evening Shift schedule: 1:00pm to 9:30pm (some flexibility possible)- Blood Banking experience Required
Werfen is seeking a Medical Laboratory Technologist II, Technical Specialist to join our Quality Laboratory team. 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
Responsibilities:
Key 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) and other duties as assigned.
- 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 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.
- 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
Qualifications:
Minimum Knowledge & Experience required for the position:
- Bachelor’s Degree in Medical Technology, Life Sciences or other science or technical field
- MT(ASCP) or equivalent (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 Evening Shift schedule: 1:00pm to 9:30pm
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.
