Vaccine Stability Quality Specialist

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Job summary

Merck & Co. seeks a Stability Specialist to support site stability programs, executing strategies for pre-commercial and commercial studies. You will manage stability studies, handle samples, protocols, and GMP documentation, and collaborate with internal and external sites globally.

The role requires a chemistry/biological science related degree and experience in GMP environments. Candidates will engage with cross functional teams and utilize LIS, Excel and statistical tools.

Qualifications

• Bachelor's degree in chemistry, biological science, pharmacy, or related field.

Responsibilities

• Manage stability studies including sample receipt, labeling, chain of custody, protocol creation, study builds and closeouts.
• Coordinate sample shipment and receipt with partner sites and labs.
• Review annual stability reviews for licensed products for accuracy.
• Respond to inquiries related to product or project stability.
• Maintain GMP documentation per company policies and procedures.
• Support deviation management and corrective actions for stability operations or testing.
• Respond to early warning limit excursions.
• Author or revise local Standard Operating Procedures.
• Use LIS, MS Word, Excel and statistical software for documentation and analysis.

Skills

Adaptability

GMP Compliance

Data Analysis

Decision Making

Documentation Review

Laboratory Operations

Quality Control

Problem Solving

Communication

Education

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

Tools

Laboratory Information Management System

Microsoft Word

Excel

Statistical software

Job description

Merck & Co. seeks a Stability Specialist to support site stability programs, executing strategies for pre-commercial and commercial studies. You will manage stability studies, handle samples, protocols, and GMP documentation, and collaborate with internal and external sites globally.

The role requires a chemistry/biological science related degree and experience in GMP environments. Candidates will engage with cross functional teams and utilize LIS, Excel and statistical tools.