JT770 - QUALITY APPLICATIONS SPECIALIST
TEMPORARY•Villalba
About this role
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Quality role to support product transfer activities, focus on sterilization machines, validation and process.
- 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.
Qualifications:
- Bachelor’s degree in related area
- 3+ years of relevant experience
- Experience with process failure mode analysis and first time quality.
- Knowledge on Sterilization Machines
- Process Validation, Statistical Analysis, Process Failure Mode and First Time Quality
- 1st shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
What you'll do
- The role involves supporting product transfer activities with a focus on sterilization machines and validation processes. It also includes conducting compliant validation processes for quality information technology systems and coordinating activities with clients and personnel.
About Quality Consulting Group
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matters.
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Frequently Asked Questions
What does a JT770 - QUALITY APPLICATIONS SPECIALIST do at Quality Consulting Group?
As a JT770 - QUALITY APPLICATIONS SPECIALIST at Quality Consulting Group, you will: the role involves supporting product transfer activities with a focus on sterilization machines and validation processes. It also includes conducting compliant validation processes for quality information technology systems and coordinating activities with clients and personnel..
Is the JT770 - QUALITY APPLICATIONS SPECIALIST position at Quality Consulting Group remote?
The JT770 - QUALITY APPLICATIONS SPECIALIST position at Quality Consulting Group is based in Villalba, Puerto Rico, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the JT770 - QUALITY APPLICATIONS SPECIALIST position at Quality Consulting Group?
You can apply for the JT770 - QUALITY APPLICATIONS SPECIALIST position at Quality Consulting Groupdirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.