Stability & Quality Assurance Specialist

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs, execute stability strategies, and manage samples, protocols, and GMP documentation across global sites.

The role involves cross-functional collaboration with internal and external partners to ensure compliance and timely study delivery. The position requires a Bachelor's degree in a related science and experience with GMP, vaccines, and analytical methods.

Qualifications

• Bachelor's degree in chemistry, Biological Science, Pharmacy, or related field.
• Experience with GMP, vaccines, biologics, and/or devices; working knowledge of analytical methods and manufacturing processes.
• Strong understanding of regulatory requirements and quality systems.

Responsibilities

• Manage stability studies for vaccines and pharmaceutical products, including sample handling, 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.
• Provide timely responses to product or project inquiries.
• Maintain GMP documentation per company policies and procedures.
• Support deviation management and corrective actions related to stability operations.
• Respond to early warning limit excursions.
• Draft or revise local Standard Operating Procedures.
• Utilize LIS, MS Word, Excel, and statistical software for stability documentation and reporting.

Skills

Aseptic Manufacturing

Biologics

cGMP Compliance

GMP Documentation

FDA Regulations

Data Analysis

Deviation Management

Laboratory Information Systems (LIS)

Quality Control Systems

Education

Bachelor's degree in Chemistry or related Science

Tools

Laboratory Information Management System (LIMS)

Microsoft Word

Microsoft Excel

Statistical software

Job description

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs, execute stability strategies, and manage samples, protocols, and GMP documentation across global sites.

The role involves cross-functional collaboration with internal and external partners to ensure compliance and timely study delivery. The position requires a Bachelor's degree in a related science and experience with GMP, vaccines, and analytical methods.