Development Scientist III Transfusion and Transplant

Overview

Job Summary

The Assay Development Scientist III Performs a variety of tasks including supervisory activities associated with the development of new products and new manufacturing process-es the investigation into and implementation of product and process changes and the transfer of new products and processes to the manufacturing departments. Oversees and provides leadership to cross functional development team in developing new products using Design Controls. Works at strategic and tactical levels by participating in identifying resources for the department including facility equipment personnel and budgetary requirements.

Responsibilities

Key Accountabilities

• Performs activities associated with the development / launch of new products and devel-opment / implementation of new manufacturing processes
• Performs departmental activities according to department procedures and / or supervisory instructions
• Completes tasks within procedure- or department-defined time frames
• Performs specified supervisory activities as directed by departmental management
• Participates in developing departmental procedures quality plans / device master records and / or work instructions
• Implements special projects and validations as needed
• Participates in training and the development of employee skills
• Performs administrative functions to ensure the appropriate day to day departmental operations
• Participates in procuring facility equipment personnel and budgetary resources required by the department
• Participates in forecasting future departmental needs for equipment / capital
• Participates in departmental internal audit process
• Ensures department records are legible and are stored according to procedure / work-instruction-defined protocols and time frames
• Follows applicable laboratory OSHA regulations with respect to chemical hazards blood-borne pathogens safety etc.
• Understands ANSI / ISO / ASQC Q9001 21 CFR 1 99 200s 800s 600s and EN46001 standards as applied to corporate quality system
• Understands source composition and characteristics of products and associated chemical and biosafety hazards
• Follows applicable company procedures for the documentation of training of employees
• Interacts cooperatively with coworkers managers and employees of other departments. Receives direction well from superiors
• Implements special projects as needed

Networking / Key relationships

Works closely with other R&D groups Systems Engineering Quality Regulatory MTS and occasionally Marketing and Clinical teams.

Qualifications

Minimum Knowledge & Experience required for the position :

Skills & Capabilities :

Travel requirements :

N / A

Key Skills

Fire Protection,Attorney At Law,Cost Estimation,Cloud Services,Art & Design

Employment Type : Full-Time

Experience : years

Vacancy : 1