Pharma QA Specialist – Hybrid, Regulatory & Complaints

MSD; Pennsylvania; Hybrid; USD 87.000 - 137.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

401(k) retirement

Paid holidays

Vacation and sick days

Zusammenfassung

Merck & Co., Inc. in West Point, PA is seeking a Quality Assurance Specialist (P2) to support health authority reporting, product complaints, and adverse event management.

You will liaise with QA, pharmacovigilance, manufacturing and regulatory affairs to ensure compliant, timely processing of quality issues. The role requires a Bachelor’s in Life Sciences or Engineering (or equivalent experience) and at least 3 years in pharmaceutical quality with GMP exposure.

Qualifikationen

• 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 is required.
• Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations is preferred.

Aufgaben

• 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.

Kenntnisse

Audits

CAPA

Documentation

GMP Compliance

Quality Assurance

Ausbildung

Bachelor’s degree in Life Sciences/Engineering

Jobbeschreibung

Merck & Co., Inc. in West Point, PA is seeking a Quality Assurance Specialist (P2) to support health authority reporting, product complaints, and adverse event management.

You will liaise with QA, pharmacovigilance, manufacturing and regulatory affairs to ensure compliant, timely processing of quality issues. The role requires a Bachelor’s in Life Sciences or Engineering (or equivalent experience) and at least 3 years in pharmaceutical quality with GMP exposure.