Quality Applications Spec

Weil Group • Villalba, PR

8d

About The Position

This Quality role supports product transfer activities, focusing on process validation and product release up to commercial release. The ideal candidate will have experience with process failure mode analysis and first-time quality. The role involves conducting compliant validation processes for quality information technology systems, requiring formal validation documentation under appropriate federal regulations. Responsibilities include coordinating activities with clients, programmers/developers, and operating personnel, both domestically and globally. The specialist will identify current and anticipated requirements for compliant computerized operations, suggest methods for implementation and maintenance of necessary procedures and documentation, and report on the status of validation activities. This position requires staying updated on changing federal and international regulatory requirements, government audit policies, and current techniques. System administration and configuration of quality information technology systems are also part of the role. As a Specialist Career Stream individual contributor, this role delivers and manages assigned projects, works with stakeholders, and may mentor colleagues or direct the work of lower-level professionals. The majority of time is spent delivering and overseeing projects from design to implementation, adhering to policies, and utilizing specialized knowledge.

Requirements

• Knowledge on Sterilization
• Knowledge in Final Pack
• Process Validation
• Statistical Analysis
• Process Failure Mode
• First Time Quality
• University Degree and minimum of 3-6 years of relevant experience, or advanced degree with 0 years of experience.

Nice To Haves

• Experience with process failure mode analysis
• Experience with first time quality

Responsibilities

• 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.
• 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.
• Oversees projects from design to implementation while adhering to policies, using specialized knowledge and skills.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level