Quality Assurance Specialist
Merck
Summary
The Quality Assurance Specialist (P2) is responsible for supporting Quality Systems processes related to Health Authority reporting, product complaint intake and assessment, adverse event management, and complaint sample coordination. This role ensures compliance with global regulatory requirements, internal quality standards, and company procedures for the timely evaluation, documentation, investigation, and reporting of product quality complaints and adverse events. The successful candidate will serve as a key liaison between Quality Assurance, Pharmacovigilance, Manufacturing, Regulatory Affairs, and external stakeholders to ensure accurate complaint processing, effective sample management, and regulatory reporting activities.
Job description
Primary Responsibilities
- Author Adverse Event Quality Investigation Reports
- Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples
- Maintain complaint sample inventory and chain-of-custody records
- Work with laboratories and investigation teams to ensure complaint samples are tested within established timelines
- Ensure complaint samples are handled and retained according to GMP and company requirements
- Support sample reconciliation activities and maintain accurate documentation
- Author Health Authority responses and notifications
- Review and update procedures, work instructions, and training materials related to complaint handling and reporting processes
- Maintain expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international)
- Review regulatory citations and other pertinent information
- Participate on teams supporting internal functions and/or evaluating site processes for improvement opportunities
- Provide information for regulatory inspections as requested
- Complete special projects or assignments as directed by management including conducting education and training on GMP requirements
Individual may have the opportunity to support other areas within the West Point Quality Assurance organization, including SOP and Batch Record Management, Audits and Inspections, Deviation Management, Annual Product Reviews, Vendor Management, Inspection Management, QMS/Quality Council Management, and Risk Management.
Education Minimum Requirement
Bachelor's degree. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience. In lieu of Bachelor's degree, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.
Required Experience and Skills
- Minimum three (3) years in Pharmaceutical Quality, Quality Assurance, Quality Systems, Product Complaints, Pharmacovigilance, or related experience with progressive and demonstrated Quality decision-making responsibility
- Experience working in a regulated GMP environment required
- Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Deliver results across multiple functional areas at the site
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
- Speaks with courage and candor
- Effective and positive written and verbal communication skills
- In-depth working knowledge and application of GMPs
Requirements
- Bachelor's degree in Life Sciences, Science discipline, or Engineering field preferred; other fields considered with significant relevant experience
- In lieu of Bachelor's degree, minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function
- Minimum three (3) years in Pharmaceutical Quality, Quality Assurance, Quality Systems, Product Complaints, Pharmacovigilance, or related experience
- Experience working in a regulated GMP environment required
- Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
- Effective and positive written and verbal communication skills
- In-depth working knowledge and application of GMPs
- Audits Compliance
- Corrective and Preventive Action (CAPA)
- Detail-Oriented
- Documentation Review
- Driving Continuous Improvement
- GMP Compliance
- Quality Assurance Tools
- Quality Auditing
- Quality Complaints
- Quality Management Systems (QMS)
- Quality Standards
- Root Cause Analysis (RCA)
- Supplier Quality Management
- Troubleshooting
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Retirement Benefits
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.