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QA Specialist
Contract : North Chicago, Illinois, US
Salary Range : 25.00 - 28.00 | Per Hour
Job Code : 357490
End Date : 2025-02-28
Days Left : 27 days, 2 hours left
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Industry : Pharmaceuticals
Job Title : QA Specialist I
Duration : 6 months, with a possible extension
Location : North Chicago, IL 60085
Pay Range : 25$-28$ / hr
Job Description :
Decision maker for all reportability decisionsLead for all vigilance reporting, including local and global submissionsPartners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriateEnsures that relevant stakeholders have visibility to the reporting and where they are in the processManages regular reporting needs and external requests (i.e., from the FDA)Manage the timeline for end-to-end reportingOwns translation services for reportingQualifications :
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 experienceWhat 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 preferredKnowledge 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.Job Requirement
documentationregulatorymedical regulationvigilenceReach Out to a Recruiter
RecruiterEmailPhoneShivani Awasthishivani.awasthi@collabera.comApply Now
Salary : $25 - $28
