WEP Clinical

Senior Quality Assurance Associate

WEP Clinical

full-time

Posted on:

Location Type: Hybrid

Location: Morrisville • North Carolina • United States

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Job Level

Senior

About the role

  • Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
  • Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorisations in line with regulatory expectations.
  • Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
  • Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
  • Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
  • Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
  • Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
  • Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
  • Coordinate product recalls and mock recalls as required.
  • Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
  • Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
  • Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
  • Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
  • Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
  • Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.

Requirements

  • Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
  • 2-5 years of experience in a Quality-related role within a regulated environment
  • Practical experience in GxP Supply Chain, Production, and Quality Assurance, with knowledge of GMP, GDP, and the supply of unlicensed medicines (including distribution supply chains and unlicensed pathways preferred)
  • Strong understanding of core Quality Management System processes, including risk assessments, deviations, change control, and supplier/customer management
  • Ability to apply a risk-based approach to prioritize tasks effectively in day-to-day activities
  • Proven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiatives
  • Strong critical thinking and analytical skills, particularly in conducting and reviewing investigations
  • Excellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlines
  • Effective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervision
  • Highly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPGDPGxPQuality Management Systemrisk assessmentsdeviationschange controlroot cause analysisCAPAbatch certification
Soft Skills
critical thinkinganalytical skillsorganizational skillsplanning skillstime managementadministrative skillsattention to detaileffective communicationinterpersonal skillsadaptability
Certifications
Bachelor's Degreepharmaceutical concentrationlife sciences concentrationengineering concentration