Stark Pharma Solutions Inc
Overview
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. Job Details
Job Title:
Quality Systems Analyst Location:
Titusville, NJ Experience:
5+ years Duration:
12+ Months 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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Staffing and Recruiting
#J-18808-Ljbffr
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. Job Details
Job Title:
Quality Systems Analyst Location:
Titusville, NJ Experience:
5+ years Duration:
12+ Months 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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Staffing and Recruiting
#J-18808-Ljbffr