BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Production Supervisor to work for a leading San Diego County biotechnology company.
Supervises the preparation of autoimmune diagnostic products, following established procedures. Major duties include bead and reagent preparation activities and the preparation of controls and conjugates for the product lines.
Supervises the preparation of product bulks and solutions required for antigen coupling according to written manufacturing documents and schedules.
Researches and corrects problems with production according to established SOPs and procedures.
Supervises the evaluation of raw materials, in-process materials and finished reagents associated with products according to written procedures and SOPs.
Prepares and performs/supervises validations for all equipment according to written protocols.
Assures detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing, evaluation and development activities in accordance with Quality Systems Regulations for the laboratory. Assists with the generation and implementation of Product Change Requests for manufacturing documents and SOPs.
Supervises the preparation, calibration, operation and cleaning of equipment used in the manufacture of products according to written SOPs.
Investigates, analyzes and carries out corrective actions for product performance or manufacturing problems in conjunction with manager and the assistance of others.
Informs manager of laboratory equipment needs and other supplies required to avoid interruptions in production schedules. Informs manager of broken or deteriorating equipment.
Supervises all tests required to improve product performance/quality and/or process efficiency for autoimmune diagnostic products as requested by supervisor.
Ensures supplies of materials, reagents and equipment required to meet schedules are available. Alerts manager of any material shortages, equipment requirements and/or other circumstances, which may cause delays in the planned schedules.
Ensures manufacturing laboratories, work areas and equipment are in a clean and functional state in order to comply with QSRs guidelines. Immediately reports all malfunctions or calibration expirations to manager.
Prepares performance reviews for individuals in the group.
Trains and/or assists with the training of individuals on the safety, technical, recordkeeping and QSRs aspects of their position.
Selects, organizes and supervises the work assignments of individuals designated to assist with those assignments.
Implements and monitors personnel compliance with established safety an environmental procedures. Reports all safety hazards immediately and initiates actions to protect personnel from injury until remedied.
BA or BS in the biological or related sciences with 4+ years of applicable laboratory ELISA experience. Excellent laboratory skills including solution preparation, manufacturing procedures and laboratory equipment operation. Knowledge of Quality Systems Regulations (QSR) and Product Change Requests (PCR) systems as they apply to diagnostics manufacturing.
BioPhase Solutions - 10 months ago
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