What are the responsibilities and job description for the Quality Assurance Specialist position at Merck?
Summary
We are seeking a Quality Specialist to support the disposition of clinical supplies for worldwide clinical trials. This role is critical in maintaining the global clinical supply chain by ensuring compliance with company policies, regulatory requirements, and Good Manufacturing Practices (GMP). The position reports to the Associate Director, Global Clinical Supplies Quality and involves reviewing stock transfer orders, releasing components and sourced drug products, and providing project support.
Responsibilities
- Review and disposition bulk drug product and components, ensuring compliance with company policies, procedures, and governing regulations.
- Coordinate and support the preparation of procedures, processes, and quality improvements.
- Assist in coordinating significant quality events, including fact-finding, investigations, and clinical quarantine/recovery actions.
- Collaborate across cross-functional and business areas to drive continuous improvement and team-building initiatives.
- Lead or participate in projects to enhance process performance, including continuous process improvements, corrective/preventative actions (CAPAs), and value capture projects to improve outcomes, reduce costs, and streamline processing cycle times.
Education
- Bachelor's degree with a technical emphasis in a scientific or engineering field preferred.
Experience
- Minimum of 2 years post-degree experience in the pharmaceutical or equivalent industry within a GMP-related field, including Technical, Engineering, Quality, or Operations.
- Previous experience in quality control, quality assurance, auditing, or regulatory affairs.
- Familiarity with batch disposition (release) activities preferred; prior batch disposition experience is a plus.
- Strong understanding of current Good Manufacturing Practices (cGMPs).
- Demonstrated leadership skills with effective oral and written communication, presentation, and conflict resolution abilities.
- Strong teamwork skills with the ability to work independently.
- High attention to detail, flexibility, and awareness of production and quality control challenges.
Preferred Skills
- Ability to independently manage multiple priorities and projects.
- Experience supporting cross-functional and multi-level teams, including senior management.
- Proficiency in SAP, Electronic Document Systems (e.g., Veeva, MEDS, Documentum), PowerPoint, Excel, OneNote, and Word.
