QA Specialist in North Chicago, IL

Position Title: QA Specialist I

Length of Contract: 1 year

, 100% Onsite, or Hybrid Onsite Schedule: Hybrid

Lake County Hybrid/Austin Hybrid

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 ly on a regular basis or is it an on-site role? If opportunity exists, what are the options (i.e. 1 day , 4 days on-site)?

• Hybrid schedule 3 days onsite and 2 days .

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