Quality Stability Specialist — GMP & Cross-Functional Impact

MSD Malaysia; Northern (KY); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Job summary

Merck & Co., Inc. at the West Point, PA site seeks a Stability Specialist to support stability programs for pre-commercial and commercial studies. You will manage sample handling, protocol creation, and study closeouts while coordinating with internal teams and external partners.

Responsibilities include coordinating shipments, reviewing stability reviews, and maintaining GMP documentation. Strong collaboration and data analysis, with a background in chemistry or related science, are essential.

Qualifications

• Bachelor's degree in chemistry, biological science, pharmacy, or related field.
• Experience with GMP compliance and quality systems.
• Experience with vaccines, biologics and/or devices is preferred.

Responsibilities

• Manage stability studies for vaccines and pharmaceuticals, including sample handling, labeling, and custody.
• Coordinate with partner sites and labs for sample shipment/receipt.
• Review annual stability reviews for licensed products and address inquiries.

Skills

cGMP Compliance

Data Analysis

Documentation Review

LIS / LIMS

Education

Bachelor's degree in chemistry, biology, pharmacy, or related field

Tools

LIS

Job description

Merck & Co., Inc. at the West Point, PA site seeks a Stability Specialist to support stability programs for pre-commercial and commercial studies. You will manage sample handling, protocol creation, and study closeouts while coordinating with internal teams and external partners.

Responsibilities include coordinating shipments, reviewing stability reviews, and maintaining GMP documentation. Strong collaboration and data analysis, with a background in chemistry or related science, are essential.