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Alexa Nicholson
Senior Talent Acquisition Specialist at The Fountain Group
Shift Details:
Monday-Friday 8AM-5PM (Hybrid after training 3 days onsite, 2 days remote)
Job Description:
This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.
Individual will work in Client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
Position is responsible for product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
Position is also responsible for ensuring that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
Qualifications:
Bachelor, masters or PharmD degree within a life science, healthcare, or health science related discipline.
Experience with complaints and/or complaint handling for product safety.
Experience with FDA regulations.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Staffing and Recruiting
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