- Performs blood processing operations according to corporate policies, operating procedures, specifications, and work instructions
- Ensures blood products are transported, processed, and stored in a manner that prevents contamination
- Follows appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices
- Performs in-process testing and visual inspections of product for defects
- Creates legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices
- Follows applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens
- Maintains a neat, clean, and orderly work environment
- Independently performs equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency
- Applies FDA regulations, and ISO standards to department operations and understands consequences of non-conformance
- Moves, stores, and inventories production supplies and materials according to department specifications
- Completes all training and qualification requirements; actively participates in on-going training and the training of new employees
- Assist and communicate with co-workers to assure all safety, quality, and efficiency objectives are achieved
- Demonstrate supportive behaviors toward co-workers and cooperate as a member of the team
- Demonstrate behaviors supportive of personal and professional growth of self and co-workers
- May perform BAAN entries (Production Orders, Material Transfers, BOMs) and data entry support, as needed
- May support and perform review of Manufacturing DHRs for RBC Processing, Solid Phase, VLP, Serum Bulk Manufacturing, and cleaning and maintenance records as needed
- Bachelors of Science degree in Biological (or related sciences) required, or Bachelor's degree with at least 3 years related laboratory experience required.
- Ability to work in a manufacturing lab environment.
- Ability to work in a cleanroom (wear gowning 90% of the time).
- Must be able to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekends
- Ability to work irregular hours and days as necessary to meet production schedules.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume
- Ability to use hands to manipulate product. Lifting, pushing or pulling various amounts of weight are required.
- Ability to stand over intervals of several hours at a time.
- Ability to check for defects, test readings, identifies and distinguish between colors to verify results.
- The majority of the work day may be spent standing. Bending, squatting and reaching are also required.
- Preferred Experience: >1 year in GMP cleanroom environment.
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RBC Processing Technologist - Norcross, United States - Immucor Inc
3 weeks ago
Description
OverviewWerfen
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 currently seeking a RBC Processing Technologist to join our team. As a RBC Processing Technician, you will perform a variety of activities in the Red Cell Processing Department.Processes red blood cells, formulates red blood cell products into a diluted (bulk) state, and performs in-process testing in an aseptic production environment.
Performs production tasks in a cleanroom environment in compliance with Good Manufacturing Practices and Good Documentation Practices.
If you've got the necessary skills and experience to excel in this 2nd shift position, we want to hear from you.
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.
RBC Processing Technologist - Manufacturing LabResponsibilities
Key Accountabilities:
Qualifications
Minimum Knowledge & Experience required for the position:
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.
