Stability Coordinator
A Stability Coordinator typically oversees the storage and testing of products or materials to ensure they remain stable over time. They are responsible for monitoring the conditions in which products are stored and ensuring that they meet quality and safety standards.
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Sample Job Descriptions for Stability Coordinator
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
As a Stability Coordinator, you will support our Quality Assurance teams by managing and tracking stability studies for our products. Your role will be critical in ensuring that product quality and compliance with industry standards are maintained over time. This entry-level position offers the opportunity to develop expertise in product lifecycle management and quality control processes.
Required Skills
- Ability to multitask and prioritize work in a dynamic environment.
- Strong analytical and problem-solving skills.
- Effective written and verbal communication skills.
- Team-oriented with a proactive work ethic.
- Basic knowledge of statistical analysis and data interpretation relevant to stability testing is a plus.
Qualifications
- Bachelor's degree in Chemistry, Pharmacy, Biology, or a related field.
- Basic understanding of FDA, ICH, and other regulatory agency guidelines.
- Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Strong organizational skills and attention to detail.
Responsibilities
- Coordinate and monitor stability testing schedules and sample management activities.
- Assist in the preparation of protocols, reports, and Stability Study documentation.
- Maintain comprehensive records of stability data according to regulatory requirements.
- Liaise with various departments such as R&D, Quality Control, and Regulatory Affairs to gather necessary information for stability studies.
- Support the investigation of out-of-trend or out-of-specification test results.
- Participate in audits and inspections related to stability studies and provide necessary documentation.
- Ensure that stability chambers and related equipment are well-maintained and calibrated.
- Assist in the review and updating of stability-related SOPs and work instructions.
Intermediate (2-5 years of experience)
Summary of the Role
The Stability Coordinator is responsible for managing stability studies in accordance with regulatory requirements and company policies. They ensure that all products meet quality standards, and that data from stability testing is accurately reported and used to make informed decisions.
Required Skills
- Proficiency in analytical techniques such as HPLC, GC, and dissolution testing
- Strong attention to detail and ability to analyze complex data sets
- Knowledge of statistical analysis and software tools
- Proven ability to work in a fast-paced, regulatory-driven environment
- Ability to work independently and as part of a team
- Problem-solving skills and a proactive approach to resolving issues
Qualifications
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related field
- 2-5 years of experience in stability testing within the pharmaceutical or biotechnology industry
- Familiarity with ICH guidelines and cGMP regulations
- Experience with data analysis and stability software
- Strong organizational and project management skills
- Excellent written and verbal communication skills
Responsibilities
- Design and implement stability study protocols according to industry guidelines
- Monitor ongoing stability tests and ensure proper storage conditions
- Analyze and report stability data to support product shelf life and storage requirements
- Coordinate with cross-functional teams to ensure compliance with regulatory standards
- Manage stability chambers, including calibration, maintenance, and troubleshooting
- Participate in the development and validation of analytical methods for new products
- Review and update Standard Operating Procedures (SOPs) related to stability testing
- Assist in the preparation of regulatory submission documents concerning stability data
Senior (5+ years of experience)
Summary of the Role
The Stability Coordinator is responsible for overseeing the stability testing programs to ensure compliance with all regulatory requirements. The role involves coordinating stability studies, analyzing data, and making sure that the products are stable over their intended shelf life.
Required Skills
- Proficiency in data analysis and statistical software relevant to stability studies.
- Strong analytical and problem-solving abilities.
- Effective leadership and team management skills.
- Detail-oriented with a high level of accuracy.
- Ability to work independently and as part of a team in a fast-paced environment.
- Adaptability to change and ability to manage stress.
- Commitment to continuous learning and staying up-to-date with industry developments.
Qualifications
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences or a related field.
- 5+ years of experience in stability testing or a related field in the pharmaceutical or biotechnology industry.
- In-depth knowledge of ICH guidelines, FDA/EMA regulations, and GMP/GLP practices.
- Proven track record of managing stability programs and successfully submitting regulatory documents.
- Experience with analytical techniques such as HPLC, GC, and dissolution testing.
- Strong organizational and project management skills to handle multiple studies simultaneously.
- Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
Responsibilities
- Developing and maintaining the company's stability testing protocols and schedules in accordance with regulatory guidelines.
- Overseeing and coordinating stability testing activities to ensure timely execution and compliance with SOPs.
- Analyzing stability data and compiling results for regulatory submissions and internal product quality assessments.
- Leading cross-functional teams to resolve any stability-related issues and to ensure continuous improvement in stability protocols.
- Liaising with regulatory agencies regarding stability requirements and submissions.
- Planning and managing the stability sample inventory and ensuring that testing is completed before the expiry of samples.
- Providing technical expertise and support for the research and development department in the creation of new products.
- Training and guiding laboratory personnel in stability testing procedures and best practices.
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