Specialist, Quality

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

The Stability Specialist will support site stability programs and be responsible for executing stability strategies and protocols for both pre-commercial and commercial stability studies. This role will facilitate stability study management, including sample receipt, sample handling, protocol creation, stability study monitoring, and all associated GMP documentation. The Stability Specialist will support cross functional teams, including our Company sites and third parties as well as domestic and international sites.

Key Functions

• Manages stability studies for vaccine and pharmaceutical products, including but not limited to sample handling and receipt, sample labeling, managing sample chain of custody, protocol creation, study builds, and study closeouts
• Collaborates with partner sites and labs to coordinate sample shipment and receipt
• Reviews annual stability reviews for licensed products for accuracy
• Addresses and provides timely responses to product or project inquiries
• Maintains GMP documentation per our Company policies and procedures
• Supports deviation management for events related to stability operations or testing of stability samples. Supports implementation of corrective actions
• Responds to early warning limit excursions
• Authors or revises local Standard Operating Procedures
• Effectively utilizes applicable computer applications, including Laboratory Information Management System, Microsoft Word, Excel, and statistical software applications

Required

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

Preferred Experience

• Prior experience in laboratory, technical services, manufacturing, regulatory and/or other Quality position
• Experience with vaccines, biologics, and/or devices
• Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance

Required Skills:

Adaptability, Adaptability, Aseptic Manufacturing, Biologics, Biology, cGMP Compliance, Chemistry, Data Analysis, Decision Making, Deviation Management, Documentation Review, Document Management, FDA Regulations, GMP Documentation, Good Manufacturing Practices (GMP), Interpersonal Relationships, Laboratory Information Systems (LIS), Laboratory Management, Laboratory Operations, Laboratory Quality Control, Pharmaceutical Sciences, Quality Auditing, Quality Control Systems, Quality Inspections, Quality Operations {+ 9 more}

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

10/3/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R417666