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About the Role
The Stability Coordinator I is responsible for all aspects of the stability sample program, including initiating and managing stability studies, protocol development, sample handling, and data reporting.
Responsibilities
- Create and maintain Master Stability Protocols based on registered requirements and in compliance with ICH/FDA guidance.
- Collaborate with project teams to define stability commitments for study design, testing requirements, and material specifications.
- Calculate the number of samples required per study based on pack types and storage conditions.
- Review specification changes for products to assess impact on Master Stability Protocols and revise protocols as needed.
- Create, review, and/or approve stability study protocols and summary report tables.
- Submit sample request forms for inclusion with production records for individual stability studies.
- Assign stability study identification numbers and quantities to individual study protocols.
- Ensure stability samples are labeled properly and stored in the correct conditioned chambers.
- Revise stability study protocols as needed throughout the study lifetime.
- Perform stability study sample pulls according to the daily schedule.
- Review and ensure correct samples are pulled and delivered to the appropriate NPI laboratory.
- Provide stability data to customers when applicable.
- Dispose of stability samples upon study completion or discontinuation.
- Work with the metrology department on chamber monitoring and maintenance.
- Participate in stability improvement projects.
- Complete corrective and preventive actions when assigned.
- Prepare stability data tables and summary reports for customer Annual Reports or ongoing regulatory review.
- Review stability summary data tables for compliance and potential trends.
- Communicate any stability issues or potential issues to laboratory management.
- Author regulatory documents and reports.
- Author and revise stability protocols.
- Maintain and implement the stability sample pull schedule.
- Review and report stability data.
- Participate in audits as required.
Requirements
- Excellent oral and written communication skills.
- Proficient in computer use (Word, Excel, PowerPoint, internet) with the ability to learn new applications.
- Ability to comprehend and follow standard operating procedures and test methods.
- Strong attention to detail and ability to multitask.
- Operates with a sense of urgency in a fast-paced environment.
- Strong organization, communication, and interpersonal skills.
Skills
- ICH/FDA regulatory guidance
- Change management systems
- Computer use (Word, Excel, PowerPoint, internet)
- Metrology
- Audits
Experience Level
- 1-3 years of pharmaceutical experience
Education Level
- Degree in life sciences
Salary/Compensations
- $62,354.00
Benefits
- Annual discretionary bonus
- Medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution)
- Dental
- Vision
- Flexible spending accounts
- Retirement savings program
- Long-term care coverage
- Paid time off (176 hours per year, prorated to hire date) inclusive of sick time
- Disability benefits
- Life insurance
- Wellness program
- 13 company recognized paid holidays per year
Equal Opportunity
- An Equal Opportunity Employer, including disability/vets