Stability & Quality Systems Specialist

Merck; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs and execute stability strategies for pre-commercial and commercial studies. The role involves study management, sample handling, protocol creation, and GMP documentation across domestic and international sites.

The candidate will communicate effectively with internal/external customers, participate in cross-functional teams, and represent stability on site initiatives and continuous improvement projects.

Qualifications

• Bachelor's degree in chemistry, biological science, pharmacy, or related field.
• Experience with vaccines, biologics, and/or devices preferred.
• Knowledge of analytical methods, manufacturing processes, and GMP compliance.

Responsibilities

• Manages stability studies for vaccines and pharmaceutical products, including sample handling and receipt, labeling, chain of custody, protocol creation, study builds and closeouts.
• Coordinates sample shipment/receipt with partner sites and labs.
• Reviews annual stability reviews for licensed products for accuracy.
• Addresses inquiries related to products or projects.
• Maintains GMP documentation per company policies and procedures.
• Supports deviation management and corrective actions for stability operations/testing.
• Responds to early warning limit excursions.
• Authors or revises local SOPs.
• Utilizes LIS, MS Word, Excel, and statistical software.

Skills

cGMP Compliance

Laboratory Information Systems (LIS)

Data Analysis

Documentation Management

Education

Bachelor's degree in chemistry, Biological Science, Pharmacy, or related Science or Engineering field

Tools

Laboratory Information Management System (LIMS)

Job description

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs and execute stability strategies for pre-commercial and commercial studies. The role involves study management, sample handling, protocol creation, and GMP documentation across domestic and international sites.

The candidate will communicate effectively with internal/external customers, participate in cross-functional teams, and represent stability on site initiatives and continuous improvement projects.