Quality Operations Specialist

Job Title : Quality Operations Specialist

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