Quality Assurance Associate jobs in United States
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WEP Clinical · 14 hours ago

Quality Assurance Associate

WEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Quality Assurance Associate will ensure compliance with Good Distribution and Manufacturing Practices while supporting the Quality team in daily tasks and managing quality-related projects.

BiotechnologyInformation TechnologyPharmaceutical

Responsibilities

Ensure GMP and GDP compliance across all regulated activities
Initiate and contribute to non-conformances, complaints, CAPAs, risk assessments, and validation protocols
Support investigations and follow up on CAPAs to ensure timely closure
Maintain and manage Quality records in the QMS, including change controls, complaints, and risk assessments
Coordinate and support internal audits, regulatory inspections, and client audits
Provide day-to-day support for quality-related enquiries across the business
Assist in the creation, review, and maintenance of GxP documentation
Support or lead the initiation and closure of Change Controls
Drive and contribute to continuous improvement initiatives within the Quality function
Generate and analyze Quality metrics and trends for management review

Qualification

GMP complianceGDP complianceQuality Management SystemGxP Supply ChainMicrosoft ExcelCritical thinkingCommunicationAdaptabilityCross-functional collaboration

Required

Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
Minimum 2 years' experience required
Practical experience in GxP Supply Chain, Production, and Quality Assurance
Knowledge of GMP, GDP, and supply of unlicensed medicines
Strong understanding of fundamental principles for core Quality Management System processes (e.g., risk assessments, deviations, change control, supplier/customer management)
Computer literacy and proficient in Microsoft Office, particularly Excel

Benefits

Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave

Company

WEP Clinical

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WEP Clinical is a specialist pharma services company that works with drug developers.

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
TJC
2021-11-17Private Equity

Leadership Team

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Robert Goodman
Chief Commercial Officer (CCO)
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Company data provided by crunchbase