Job Title: Quality Systems Analyst
Location: Titusville, NJ
Experience: 5+ years
Duration: 12+ Months
Job Summary:
The Quality Analyst will support Commercial Quality activities, including controlled substance compliance, product quality complaints, change control, documentation, and internal/supplier audits. The role ensures adherence to environmental policies and procedures while supporting quality and compliance initiatives.
Key Responsibilities:
Process Know Your Customer (KYC) applications for controlled substance purchases (50%)
Conduct routine data analysis for Suspicious Order Monitoring (10%)
Manage day-to-day Product Quality Complaints (PQC) in quality systems: evaluate complaints, assign investigations, conduct investigations, and prepare investigation summaries. Ensure timely completion with stakeholders (10%)
Process quality events and change control records in Trackwise/COMET systems (10%)
Coordinate documents and procedures in truVault and other document management systems (10%)
Coordinate internal and supplier audits, including logistics, preparation, audit plan drafting, execution support, audit responses, CAPA management, and documentation in Trackwise. Ensure all audit commitments are completed on time (10%)
Education Requirements:
Required: BA/BS in Technical or Life Science field
Preferred: MA/MS/MBA in Business, Technical, or Life Science field
Experience and Knowledge:
Minimum 5 years' experience in the pharmaceutical or related industry
Up-to-date knowledge of pharmaceutical legislation, GMP/GDP, and DEA regulations
Experience working within a quality organization
Familiarity with regulatory requirements affecting Market Quality and experience with regulatory inspections
Skills:
Proficient in Trackwise/COMET, including generating queries, reporting, and data analysis in Excel
Results-driven with focus on achieving stretch goals
Strong relationship-building and collaboration skills across IT, Manufacturing, Regulatory Affairs, Commercial, and Quality teams
Understanding of regulatory inspections and compliance requirements
Core Competencies:
Credo Values
Innovation
Mastery of Complexity
Customer/Marketplace Focus
Independent Partnering
Additional Responsibilities:
Support enterprise-level quality and compliance initiatives
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