RBC Processing Technologist

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

• Bachelor's 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.
• 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.