Job Title: Stability Specialist
Location: Remote
Job Summary: We are seeking a detail-oriented professional to support product quality teams by managing stability programs for late-stage clinical and commercial products. Our team is looking for someone who can combine GMP knowledge, strong data management, and technical writing skills to help produce compliant documentation, support inspections, and contribute to continuous improvement efforts.
Responsibilities:
- Build, monitor, and manage product stability studies within GMP quality systems.
- Author and maintain GMP technical documents, stability reports, and regulatory-quality content in compliant systems.
- Provide stability data reports using electronic reporting tools and coordinate data collection, review, verification, and archiving.
- Collaborate with global and offshore teams to support audits, inspections, annual product reviews, annual reports of minor changes, and team development activities.
Required:
- Strong understanding of GMP requirements, US FDA regulations, and ICH regulations.
- Proven scientific data management and organizational skills with exceptional attention to detail.
- Demonstrated technical writing ability to author regulatory-quality documents.
- Ability to deliver accurate results on time within GMP quality systems such as Veeva, LIMS, and Spotfire.
- Excellent written and verbal communication skills with the ability to build cross-functional relationships and work independently across time-sensitive activities.
- Must meet one of the stated basic qualification pathways: Doctorate in a Life Sciences or Engineering discipline; Master’s degree with 3 years of relevant experience; or Bachelor’s degree with 5 years of relevant experience.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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