Summary of Primary Responsibilities:
Executes stability program to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements.
- Oversee monitoring of stability storage conditions, stability samples and status of laboratory test results ensuring stability programs’ progress according to the established protocols
- Develop stability study protocols and establish strategies for stability studies of new products
- Submit stability samples to analytical laboratories when required
- Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures
- Participate directly with external departments (e.g. Engineering, Regulatory, Manufacturing and Quality Control) to address problems identified during stability studies
- Perform and review analysis of stability data and author stability technical reports
- Interpret complex, explicit documentation for new and current compliance procedures
- Compare regulatory agency enforcement action/trends to our current procedures and stability programs and identify potential problem areas
- Defining & Determining Shelf Life and Confidence Levels
- Validating Model Assumptions and Handing Non-Normal Response Data
Substantial work with Microsoft Word to write protocols and reports requiring the ability to interpret results. Substantial work with Microsoft Excel requiring the ability to statistically analyze data and perform trending analysis. Helps to resolve problems related to generation of lab data, applies thorough analysis and evaluates intangible variables to reach logical conclusions. Processing received samples requiring strong organizational and administrative skills. Can work with analysts to make corrections on generated lab data.
Experience, Knowledge, and Skills Required:
- Minimum of 5 years (Bachelor) or 0-2 years (Master) experience in the Medical Device/Pharmaceutical industry; BS in Chemistry or other Physical Science preferred
- Experience in Life Data Analysis Approach for Determining Shelf Life and Accelerated aging
- Knowledge and use of Regression Modeling (Linear and Non-Linear) to Assess Stability/Shelf Life
- Proficient knowledge in current regulations and guidance documents including cGMP, ICH, FDA, and EMA requirements
- Experience with data trending and statistical programs (JMP, MiniTab, Excel, etc) preferred
- Ability to work independently
- Strong technical writing skills
- Requires lab administrative experience
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.