Danielle Cobb Email & Phone Number

Minneapolis, MN, US

• Develops and revises procedures and work instructions through various PLMs. Revisions related to changing requirements and process improvements
• Monitors records control process performance including site metrics. Utilize quality tools to proactively track and trend quality performance data leading to quality solutions and improvements. Includes CAPA.
• Internal auditing of quality system processes
• Perform product release activities including… Show more
• Perform product release activities including the review and approval of sterilization batch records to ensure that all processing parameters have been met
• Coordinates internal and external post production activities related to nonconformances. E

• Serve as site CAPA Coordinator. Duties include ensuring CAPA records comply with established procedures, maintaining electronic and paper CAPA records, acting as local administrator for learning management systeme.
• Serve as Records Coordinator. Duties include coordinating retrieval and shipment of quality and business records for long term storage and managing database used to track stored boxes. Manages library of Device History.
• … Show more
• Author and/or maintain upkeep of procedures and work instructions for areas of responsibility. Show less

Cedar Rapids, Iowa Area

• Review quality control and maintenance paperwork for equipment and materials associated with automated plasmapheresis, information gathered while screening individuals for plasma donation, and the associated documents.
• Ensure employees are performing job duties per standard operating procedures through direct observation and review of their competencies demonstrated through… Show more
• Ensure employees are performing job duties per standard operating procedures through direct observation and review of their competencies demonstrated through the Biolife Technical Training Program. Ensures medical.
• Address deviations, as a result of both internal and external factors, from standard operating procedure based on severity via CAPA management.
• Conduct a focused audit every month concerning one of eleven key quality systems. Prepare for and lead internal and governmental audits and inspections.
• Coordinate management review meeting and participates in center staff meetings. Show less

Coralville, IA

• Review quality control and maintenance paperwork for equipment and materials associated with automated plasmapheresis, information gathered while screening individuals for plasma donation, and the associated documents.
• Ensure employees are performing job duties per standard operating procedures through direct observation and review of their competencies demonstrated through… Show more
• Ensure employees are performing job duties per standard operating procedures through direct observation and review of their competencies demonstrated through the training program.
• Address deviations, as a result of both internal and external factors, from standard operating procedure based on severity via CAPA management.
• Assist Quality Manager with monthly quality system audit.
• Perform and train other employees in equipment maintenance and calibaration, medical historian duties, phlebotomy, and plasma processing duties. Show less