QA Specialist I

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:

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.