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QA Specialist
North Chicago, IL
Job Description
Job Title: QA Specialist
Duration: 12 Months
Location: North Chicago, IL, 60085 (HYBRID)
Details:
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.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Duration: 12 Months
Location: North Chicago, IL, 60085 (HYBRID)
Details:
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.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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