Position Purpose

To support the quality assurance processes  as part of the Dynamic Quality Assurance (DQA) Program in support of the FAMI-QS and GMP+ Standards. 

Key Responsibilities

• Provides support for various elements of the Quality Management System (QMS)
• Assists in completion and distribution of Certificates of Analysis and Certificates of Conformance for both domestic and international shipments
• Assists in reviewing issues concerning internal and external failures and implementing process or system changes
• Assists in completion of Technical Data Sheets and Safety Data Sheet requirements for both domestic and international needs
• Effectively interacts with all departments as part of performing normal job duties
• Assists in completion of requested regulatory documentation
• Provides assistance and backup to Quality Assurance Specialist and Quality Coordinator in day-to-day activities
• Assists in obtaining and maintaining supplier approval documentation
• Schedule and coordinate manufacturing validation plans

Competencies

Technical/Operational

• Ability to efficiently utilize various processes to obtain required information to complete work assignments
• Ability to perform multiple tasks and prioritize workload
• Ability to effectively interact with internal and external personnel

Personal

• Ability to manage multiple programs and projects
• Well organized and efficient in handling a variety of administrative tasks
• Good communication skills (interpersonal, written and presentation)

Education & Additional Requirements

• High School Graduate or G.E.D. Equivalent; some college course work preferred
• Intermediate typing skills
• Personal computer knowledge and computer software experience, Microsoft Word and Excel required
• JDE experience preferred