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Qa Specialist I Job In North Chicago, Illinois, Kyyba, Inc

Published 2022-10-01
Expires 2022-11-01
ID #1196517420
Free
Qa Specialist I Job In North Chicago, Illinois, Kyyba, Inc
United States, Illinois, North Chicago,
Published October 1, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Qa specialist i
Remote:
Work from home:


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Description

Notes:

5 to 10 openings total (both Austin, TX and LC locations)

Max bill rate info for Lake County, Il: /hr.

Please only submit Lake County or 100% remote workers to this posting



If candidate has preferred qualification of Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) can go to /hr in Il location.



Purpose: The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

Responsibilities:

" Decision maker for all reportability decisions

" Lead for all vigilance reporting, including local and global submissions

" Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate

" Ensures that relevant stakeholders have visibility to the reporting and where they are in the process

" Manages regular reporting needs and external requests (i.e. from the FDA)

" Manage the timeline for end to end reporting

" Owns translation services for reporting

Qualifications:

" Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

" Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.

" Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

" Solid written/verbal communication and organizational skills.

" Knowledge and application of computer systems for word processing and complaint management.

" Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.



Years of experience/education and/or certifications required:

" 1+ year experience



What are the top 3-5 skills requirements should this person have?



" Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

" Solid written/verbal communication and organizational skills.

" Knowledge and application of computer systems for word processing and complaint management.

" Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.



What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

" Degree is preferred

" Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

" Clinical background including bio background, nursing, physicians from other countries without US practice has worked out as well.



Work Schedule (Define days,# of hours)/ Is Overtime offered or required?

" Start times are flexible after training



Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?



" Prefer them to be local to Austin, TX or Lake county and would be hybrid schedule 3 days onsite and 2 days remote.



Discovery Questions

" Reason for opening: Backlog



Interview Process

" 30 minute video interview

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    Registered on October 7, 2017

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    Information technology (IT) is the application of computers to store, study, retrieve, transmit, and manipulate data, or information, often in the context of a business or other enterprise. IT is considered a subset of information and communications technology (ICT). In 2012, Zuppo proposed an ICT hierarchy where each hierarchy level "contain[s] some degree of commonality in that they are related to technologies that facilitate the transfer of information and various types of electronically mediated communications". The term is commonly used as a synonym for computers and computer networks, but it also encompasses other information distribution technologies such as television and telephones. Several industries are associated with information technology, including computer hardware, software, electronics, semiconductors, internet, telecom equipment, and e-commerce. Humans have been storing, retrieving, manipulating, and communicating information since the Sumerians in Mesopotamia developed writing in about 3000 BC, but the term information technology in its modern sense first appeared in a 1958 article published in the Harvard Business Review; authors Harold J. Leavitt and Thomas L. Whisler commented that "the new technology does not yet have a single established name. We shall call it information technology (IT)." Their definition consists of three categories: techniques for processing, the application of statistical and mathematical methods to decision-making, and the simulation of higher-order thinking through computer programs.


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