Job Title: Quality Associate
Location: Princeton, New Jersey (On-site)
Job Summary: We are seeking a dedicated professional to ensure Good Manufacturing Practice (GMP) compliance for clinical manufacturing, packaging, labeling, and testing activities. Our team values collaboration across internal functions and external vendors to support product quality throughout the drug development process.
Responsibilities:
- Review manufacturing and packaging batch records for accuracy and compliance with company and GMP requirements.
- Utilize digital systems to enter batch information and manage disposition workflows, escalating issues as appropriate to ensure resolution.
- Maintain and organize GMP records, and review analytical test results to support compliance and documentation standards.
- Support process improvement initiatives, quality event records, and metrics or reporting related to product batch review and release.
Required:
- Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific discipline.
- 2–5 years of experience in the pharmaceutical industry within Manufacturing, QA, or QC supporting GMP activities for Investigational Medicinal Product or Clinical Trial Material.
- Experience using MS Office applications (Word, Excel, PowerPoint), collaborative platforms such as Teams/SharePoint, and digital quality management systems (e.g., TrackWise Digital or similar eQDMS workflow interface).
- Demonstrated understanding of GMP requirements, analytical problem solving, effective communication, and the ability to manage multiple tasks within a team environment.
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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