Production Scientist - Transfusion and Transplant

Responsibilities

• Perform the following activities in a quality focused cGMP manufacturing environment:
• BeadChip carrier assembly - involves manual and automated equipment processes.
• Formulate custom bulk reagents - involves working with pipettes and balances.
• Bulk and fill reagent manufacturing.
• Weighing, diluting, measuring and verifying chemicals for in-process solutions.
• Packaging of carrier and reagent boxes.
• Ensure materials and equipment are available in inventory for production as required.
• Follow manufacturing schedule.
• Report issues and concerns to management.
• Perform equipment setup, operation, re-supply, documentation, cleaning, minor equipment adjustments and minor preventative maintenance tasks to meet standards for safety, quality and efficiency.
• Follow GMP documents (e.g., SOPs, Work Instructions, Manufacturing Records) with strict adherence to safety and compliance.
• Create legible written records within batch records/forms.
• Write, revise and update manufacturing documentation.
• Maintain a clean and organized working lab environment.
• Responsible for training on all procedures assigned.
• Ensure all training is up to date and appropriately documented.
• The ability to be cross trained to assist in other production areas /departments as needed.
• Follows OSHA safety regulations for bloodborne pathogens.

Qualifications

• Bachelors Degree in a Science related field.
• Preferred cGMP manufacturing experience and/or training.
• Basic knowledge of MS Office and software systems used in product support.