Quality Engineer II

Cencora•Puerto Rico, TX

3d•Onsite

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: 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).

Requirements

Knowledge of Good Manufacturing Practices
Good oral and written communication skills (English and Spanish)
Computer knowledge (Excel, Word, Power Point, etc.)
Good problem-solving skills
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Nice To Haves

Availability to work overtime and weekends when necessary

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.
Performs system administration and configuration of quality information technology systems.
Performs investigation non-conformance events
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