Quality Specialist - II

Summary
This role supports the Global Clinical Supplies Quality team in maintaining the global clinical supply chain. The position is essential for ensuring compliance and efficiency in the disposition of clinical supplies used in worldwide clinical trials. The individual will be responsible for reviewing and approving stock transfer orders, release of components, sourced drug products, and providing project support. This hybrid role offers a flexible schedule and is based in Rahway, NJ.

Responsibilities

• Review and disposition sourced bulk drug products, ensuring compliance with company policies and regulatory requirements.
• Review and approve Stock Transfer Orders to confirm compliance with applicable policies and governing regulations.
• Coordinate and support the development of procedures, processes, and quality improvement initiatives.
• Assist in managing significant quality events, including fact-finding, investigations, and coordination of clinical quarantine and recovery actions.
• Collaborate with cross-functional teams to enhance processes, ensure continuous improvement, and foster team building.
• Support projects aimed at process performance improvement, including Corrective/Preventative Actions (CAPAs), continuous process improvements, and cost/time efficiency initiatives.

Education

• Bachelor’s degree in a scientific or engineering field with a technical emphasis preferred.
• Master’s or advanced degree preferred.

Experience

• Minimum of 4 years of post-degree experience in the pharmaceutical or equivalent GMP-related industry, including technical, engineering, quality, or operations roles.
• Experience in batch disposition (release) activities is preferred; prior batch disposition experience is a plus.
• Background in quality control, quality assurance, auditing, or regulatory affairs.
• Strong problem-solving skills and creativity in technical challenges.
• Working knowledge of current Good Manufacturing Practices (cGMPs).
• Proven leadership skills and strong oral and written communication abilities, including presentations and conflict resolution.
• Ability to work independently while demonstrating strong teamwork skills.
• Attention to detail, flexibility, and awareness of production and quality control challenges.

Preferred Experience and Skills

• Ability to manage multiple priorities and projects independently.
• Experience supporting cross-functional, multi-level teams, including senior management.
• Proficiency in SAP, Electronic Document Systems (e.g., Veeva, MEDS, Documentum), and Microsoft Office Suite (PowerPoint, Excel, OneNote, Word).

Additional Information

• Positions available: 2
• Hybrid role with a flexible schedule
• Work location: Rahway, NJ