Stability Program Coordinator

Job Description

Stability Coordinator

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and be part of a company that is making a difference.

Responsibilities

• Draft, review, and maintain stability protocols and amendments in alignment with ICH guidelines, internal SOPs, and regulatory commitments.
• Define study design parameters, storage conditions, timepoints, and analytical test plans.
• Author stability study plans, change controls, and protocol deviations/justifications as required.
• Ensure controlled document lifecycle management in the appropriate QMS.
• Generate and manage stability pull schedules; execute and/or coordinate stability pulls at defined timepoints.
• Oversee sample chain-of-custody, storage placement, and reconciliation, including management of chambers/incubators and alarms.
• Coordinate timely sample handover to QC labs and track testing progress through completion.
• Perform GLIMS verification, and status tracking for stability tests and results.
• Ensure accurate metadata and consistent data integrity.
• Support GLIMS static data configuration for stability studies in collaboration with LIMS admin.
• Compile, review, and interpret stability data; perform trend analysis.
• Generate interim updates and Annual Product Quality Review stability sections.
• Prepare Stability Summary Reports for regulatory submissions/variations and internal governance.
• Ensure adherence to GMP, GDP, data integrity, and site/global SOPs.
• Investigate OOS/OOT/atypical trends; author or contribute to investigations, CAPAs, and change controls.
• Maintain audit/inspection readiness; support internal and external audits for stability scope.
• Serve as site stability point-of-contact with Global Stability and CMC teams.
• Partner with QC Leads on methods, method changes, and specification updates.
• Collaborate with Supply Chain on sample availability, kit building, and calendar alignment; with QA on approvals and releases.
• Own and drive improvements in stability workflows, scheduling, chamber utilization, and data visualization.
• Support digitalisation efforts, KPI reporting, and harmonization with global standards.

Qualifications

Required

• Degree Qualification (Science/Technical/Quality or related)
• 4 years’ experience in the biotechnology and/or pharmaceutical industry
• Excellent written and oral communication skills
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance
• Ability to work on own initiative and as part of a team
• Excellent time management & organizational skills
• An understanding of GMP, ICH, USP and global compendia regulations and guidance
• Demonstrated understanding of continuous quality/process improvement tools
• Proven ability to work cross-functionally, focusing on meeting and tracking to schedules
• Flexible, self-motivated, and embracing an interdependent work culture
• Organization skills – Ability to manage multiple priorities and know when to escalate issues for resolution

Preferred

• Lean Six Sigma experience
• GLIMS proficiency (study setup, sample login, result entry/approval, reports)
• Solid understanding of stability chambers, mapping, qualification, and alarm management
• Data integrity principles (ALCOA+) and document control in QMS
• Statistical literacy for trend analysis and OOT detection (basic regression, control charts)

Required Skills:

Accountability, Alarm Management, cGMP Compliance, Communication, Data Analysis, Decision Making, Documentation Review, FDA Regulations, GMP Compliance, IS Audit, Laboratory Operations, Laboratory Quality Control, Quality Operations, Regulatory Compliance, Strategic Alignment

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/25/2026

*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.