QA Specialist I - Tellus Solutions
North Chicago, IL 60064
About the Job
Tellus Solutions is in partnership with a committed biopharmaceutical company in North Chicago focused on providing innovative therapies. Your technical expertise as a QA Specialist I in the Quality Assurance will contribute to our client's innovative therapies which will impact the quality and duration of life.
Job Description:
Purpose:
Responsibilities:
Qualifications:
Job Description:
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 report ability 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.
Source : Tellus Solutions