6 qa specialist i hybrid Jobs in austin, tx
US Tech Solutions is Hiring a QA Specialist I Near Austin, TX
•Start times are flexible after training
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.
- 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
- 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.
- 1 year experience
- 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.
•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.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Summary
Full Time
$65k-81k (estimate)
06/26/2024
07/12/2024
ustechsolutions.com
JERSEY CITY, NJ
1,000 - 3,000
1977
Private
MANOJ AGARWAL
$200M - $500M
IT Outsourcing & Consulting
Related Companies
About US Tech Solutions
US Tech is an on demand staffing company that provides workforce solutions to business customers.
The following is the career advancement route for QA Specialist I positions, which can be used as a reference in future career path planning. As a QA Specialist I, it can be promoted into senior positions as a Quality Assurance Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Specialist I. You can explore the career advancement for a QA Specialist I below and select your interested title to get hiring information.
