Quality Assurance eSystem Specialist
Newark Metro Area, NJ
Purpose and Scope of Position
The Quality Assurance eSystem Specialist s primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. The Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of products.
Required Competencies: Knowledge, Skills, and Abilities
Knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.
Knowledge of electronic batch records, Microsoft Word, Outlook, and Excel.
Requires ability to communicate appropriately with regulatory agencies.
Intermediate written and verbal communication skills.
Intermediate problem-solving, critical-reasoning, and decision-making skills.
Intermediate time-management, organizational, and multi-tasking abilities.
Ability to work independently for extended periods of time
Ability to interpret / write technical documents.
Ability to solve routine and complex problems.
Education and Experience
Bachelor s degree preferred, preferably in Science or Engineering.
3 years relevant work experience required in the pharmaceuticals or related industry.
1 year of experience supporting electronic quality systems.
An equivalent combination of education, experience and training may substitute.