Job Description

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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