Quality Assurance Associate jobs in United States
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ERGOMED · 12 hours ago

Quality Assurance Associate

Ergomed is a specialized mid-size pharmacovigilance service provider dedicated to supporting pharmaceutical and biotechnology partners. The QA Associate will support the QA team in managing internal and external audits, ensuring compliance with PrimeVigilance procedures, and maintaining audit-related documentation and trackers.

ChemicalMedicalPharmaceutical

Responsibilities

Supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Quality Audits Manager and/or Director, Quality
Supports PrimeVigilance functional teams pre-, during and post-audit by clients or by internal QA function
Assists in client specific requests for audit scheduling
Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint
Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities
CAPA Support Activities
Supports in tracking of the vendor audit CAPAs
Support in the facilitation and review of vendor CAPA responses
Input into the global audit CAPA tracker
Ensures documents and trackers from internal system and/or vendor audits initiated by Primevigilance, are kept up to date
Assists in the development and maintenance of the internal risk assessments
Conducts other ad-hoc activities as requested by Quality Audits Manager and/or Director, Quality

Qualification

Scientific degreeAudit supportCAPA trackingRisk assessmentCollaboration

Required

University degree in a scientific discipline, or equivalent industry experience

Benefits

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

Company

ERGOMED

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Ergomed provides specialized services to the pharmaceutical industry and the development of new drugs.

Funding

Current Stage
Public Company
Total Funding
$5.56M
2023-09-04Acquired
2018-02-01Post Ipo Equity· $5.56M
2014-07-15IPO

Leadership Team

G
Gordana Tonković
Strategic Development
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Sladana Sturlic
Chief of Staff
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Company data provided by crunchbase