RBC Processing Technologist

Overview We are currently seeking a RBC Processing Technologist to join our Red Blood Cell Processing 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. This position is not eligible for sponsorship for work authorization. Responsibilities 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 towards 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. Performs other duties as assigned by RBC Processing Management. Qualifications Bachelors of Science degree in Biological (or related sciences) required, or Bachelor’s degree with at least 3 years related laboratory experience required. Preferred Experience: >1 year in GMP cleanroom environment. Must be able to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekends. Experience working in an aseptic environment, preferred. Must be able to complete courses and/or assessments related to aseptic technique and gowning. The employee must then be able to work while aseptically gowned in a clean room environment. The employee must maintain their personnel environmental monitoring results within specifications. Available for temporary assignment to other areas for skills development or to support company needs. Must be able to work irregular hours and days as necessary to meet production schedules. Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume. Using hands to manipulate product. Lifting, pushing or pulling various amounts of weight are required. Overhead storage may require reaching for product/supplies. 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. 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr Werfen North America