Quality Manager, Stability
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Summary
As the Stability Manager of the BCD Stability Program you will lead the development and implementation of a harmonized stability program across the network. This role involves managing customer studies new product introductions (NPI) and excursion studies ensuring data integrity and maintaining compliance with regulatory requirements. You will lead all aspects of testing documentation and communication of stability data in addition to aiding customer inquiries and crafting memos to request extensions.
Key Responsibilities:
- Program Development and Management:
- Take charge of developing and implementing a uniform stability initiative throughout the network.
- Manage customer studies new product introductions (NPI) and excursion studies.
- Assess the current stability program and identify any gaps in product testing. Updating data for shipping studies and legacy products
- Data and Documentation:
- Supervise the collection management and analysis of stability data.
- Ensure accurate and timely documentation of all stability testing and results.
- Write memos for extensions and ensure all documentation meets regulatory standards.
- Communication and Compliance:
- Communicate and resolve path forward for any out-of-specification (OOS) results.
- Support customer inquiries related to stability data and testing.
- Ensure all procedures are followed for stability processes and meet regulatory requirements.
- Regulatory and Quality Assurance:
- Ensure the stability program complies with all relevant regulatory requirements.
- Continuously monitor and improve stability testing procedures to maintain high-quality standards.
Qualifications:
- Bachelors degree in Chemistry Biology Pharmaceutical Sciences or a related field.
- Extensive hands-on experience in stability testing quality management or a related field.
- Strong understanding of regulatory requirements and quality assurance practices.
- Excellent communication and documentation skills.
- Ability to manage multiple projects and prioritize tasks effectively.
- Strong analytical and problem-solving skills.
Preferred Qualifications:
- Advanced degree in a related field.
- Proficiency in coordinating the creation and control of stability programs.
- Familiarity with industry-standard stability testing protocols and software.
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
