QA Specialist, Adverse Event & Regulatory Reporting

Merck & Co.; West Point (PA); Hybrid; USD 87,000 - 137,000; Full time

Job summary

Merck & Co. in West Point, PA is seeking a Quality Assurance Specialist (P2) to support global quality systems, health authority reporting, and product complaint intake.

You will coordinate sample disposition, investigate adverse events, and ensure compliance with GMPs and regulatory requirements. The role serves as liaison among QA, pharmacovigilance, manufacturing and regulatory teams, preparing Health Authority responses and maintaining documentation.

Qualifications

• 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 in a regulated GMP environment required.
• Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred.

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.
• Maintains expert level of knowledge relating to core internal procedures and applicable regulations.

Skills

Audits

CAPA

Detail-Oriented

Documentation Review

GMP Compliance

QMS Tools

Quality Auditing

Quality Complaints

Root Cause Analysis

Supplier Quality

Troubleshooting

Education

Bachelor's degree in Life Sciences, Science or Engineering (preferred)

Job description

Merck & Co. in West Point, PA is seeking a Quality Assurance Specialist (P2) to support global quality systems, health authority reporting, and product complaint intake.

You will coordinate sample disposition, investigate adverse events, and ensure compliance with GMPs and regulatory requirements. The role serves as liaison among QA, pharmacovigilance, manufacturing and regulatory teams, preparing Health Authority responses and maintaining documentation.