Job Title: Quality Associate
Location: Princeton, New Jersey (On-site)
Job Summary: We are seeking a skilled professional to support critical Quality Assurance operations for outsourced clinical manufacturing, packaging, labeling, and testing activities. Our team is focused on ensuring GMP compliance and maintaining the highest standards in drug development processes.
Responsibilities:
- Perform QA review of drug product manufacturing and packaging batch records, ensuring accuracy and compliance with all relevant requirements.
- Utilize TrackWise Digital eQDMS System to enter batch-related information and complete associated batch disposition workflows.
- Maintain GMP records efficiently, including document storage, archiving, and retrieval.
- Review analytical test results and raw data to verify results meet specifications and are properly documented.
Required:
- Bachelor’s degree in Engineering, Chemistry, Biology, or related Science discipline.
- 2-5 years of experience in the pharmaceutical industry, supporting GMP activities for Investigational Medicinal Product or Clinical Trial Material in Manufacturing, QA, or QC roles.
- Experience using MS Office applications (Word, Excel, PowerPoint) and collaborative repositories such as Teams or SharePoint.
- Ability to work independently, manage and prioritize multiple tasks, and effectively handle interactions and resolve issues with internal customers and GMP vendors.
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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