Job Title: Pharmaceutical Quality Analyst
Location: Titusville, NJ
Experience: 5+ years
Duration: 12+ Months
Job Summary:
The Pharmaceutical 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
What We Offer: The Registered Nurse serves as a leader of the healthcare team at Novant Health by establishing an authentic personalized... ...nursing required. If your RN nursing license has been inactive, retired or lapsed for five years or more and you have not been licensed...
...THE ROLE As a key member of the Meat/Seafood department leadership team, the Meat/Seafood Assistant Team Leader has a breadth of responsibilities spanning from team member development and sales generation, to product management and merchandising. In this role, you...
...committed to meeting the Paris Agreements goals by 2050. Legal Counsel Clean Energy Provide advice and counsel to... ...relevant legal experience, preferably at a major law firm or in?house. R enewable energy experience; wind energy, battery storage or...