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Bioflash Diagnostic Product Specialist
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We are seeking a highly skilled and detail-oriented Bioflash Diagnostic Product Specialist to join our team at Werfen. As a key member of our diagnostic product development team, you will be responsible for preparing autoimmune diagnostic products utilizing the Bioflash technology platform.
Key Responsibilities- Prepare Bioflash product bulks and solutions required for antigen coupling according to written manufacturing documents and schedules.
- Research and correct problems with Bioflash production according to established Standard Operating Procedures (SOPs) and procedures.
- Assist with the evaluation of raw materials, in-process materials, and finished reagents associated with Bioflash products according to written procedures.
- Prepare and perform validations for all Bioflash equipment according to written protocols.
- Maintain detailed Device History Records, laboratory notebooks, and/or any associated documentation for all manufacturing, evaluation, and development activities in accordance with Quality Systems Regulations (QSRs).
- Assist with the generation and implementation of Engineering Change Orders (ECOs) for manufacturing documents and SOPs.
- Prepare, calibrate, operate, and clean equipment used in the manufacture of Bioflash products according to written SOPs.
- Investigate, analyze, and carry out corrective actions for Bioflash product performance or manufacturing problems in conjunction with supervisor and the assistance of others.
- Inform supervisor of laboratory equipment needs and other supplies required to avoid interruptions in production schedules.
- Carry out all tasks required to improve product performance/quality and/or process efficiency for Bioflash autoimmune diagnostic products as requested by supervisor.
- Maintain work area and laboratory in a clean and orderly manner.
- Follow established safety and environmental procedures. Report all safety hazards immediately.
- Bachelor's degree in the biological or related sciences.
- 1-2 years of laboratory experience.
- Working knowledge and/or laboratory skills in the area of solution preparation, immunochemistry conjugation techniques, computer operation procedures, and laboratory equipment operation.
- Knowledge of QSR and Engineering Change Orders (ECOs) systems as they apply to diagnostics manufacturing.
