Responsibilities may include the following and other duties may be assigned.
Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
Reports on the status of validation activities to fulfill regulatory requirements.
Performs system administration and configuration of quality information technology systems.
Performs investigation non-conformance events
Knowledge of Good Manufacturing Practices
Good oral and written communication skills (English and Spanish)
Computer knowledge (Excel, Word, Power Point, etc.)
Availability to work overtime and weekends when necessary
Good problem-solving skills
Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures
Verifies the implementation and effectiveness of non-conforming CAPA
Executes job responsibilities as established in the procedures
Follows the documentation procedures Non- Conformance Resolution
Evaluating, Investigating & Completion of Non- Conformance
Investigation ( Data gathering of Quality issue)
Identify Corrective/Preventive Actions
Implementing Corrective/Preventive Actions
Lead complaint activities with the Operating Units members

Must Have: Minimum Requirements
Bachelor’s degree required.
relevant experience
Fully Bilingual
Able to set effective priorities and implement decisions to achieve immediate goals
 

Education Required: Bachelors Degree
Years’ Experience Required: 2yrs

JOB DESCRIPTION
Responsibilities may include the following and other duties may be assigned. Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques. Performs system administration and configuration of quality information technology systems. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 or more years of relevant experience, or advanced degree with 0 years of experience.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*