Specialist, Quality

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.

The employee will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site initiatives and continuous improvement projects.

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

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

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The salary range for this role is

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.