Quality Analyst

About the role

This position supports quality activities for Commercial Quality, including controlled substance requirements, quality complaints, change control, documentation, and internal/supplier audits. This role adheres to environmental policies and procedures and supports departmental environmental objectives.

Key Responsibilities

• Process Know Your Customer applications to purchase controlled substances.
• Conduct routine data analysis for Suspicious Order Monitoring.
• Process day-to-day product quality complaints (PQC) in the quality system, including evaluating PQCs, assigning investigations, conducting investigations, and writing investigation summaries.
• Proactively manage PQC workflows with stakeholders to ensure all investigations are completed in a timely manner.
• Process daily quality events and change control records in electronic management systems.
• Coordinate documents and procedures in electronic management systems or other document management systems.
• Coordinate internal and/or supplier audits, including logistics/preparation for audits, drafting audit plans, supporting audit execution, coordinating audit responses and CAPA with stakeholders, and creating and documenting audit records in the system.
• Ensure all audit commitments are delivered on time.

Required Skills and Experience

• Bachelor's degree.
• Minimum of 2 years of experience in the pharmaceutical or related industry supporting Quality and Compliance Initiatives.
• Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP.
• Up-to-date knowledge of DEA regulations.
• Experience working in a quality organization.
• Experience in electronic management or quality management systems.
• Data analysis experience, including generating queries and reports.
• Results-driven individual who commits to stretch goals and delivers results.
• Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial, and Quality functional groups.
• Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and the client more broadly.
• Experience in dealing with regulatory inspections and inspection requirements.

Preferred Skills and Experience

• Advanced degree.
• Experience supporting Quality and Compliance Initiatives from Enterprise Quality and/or Global Business Quality.

This position is open to candidates located in Titusville, NJ and Horsham, PA.