Job Title: Global Product Quality Specialist
Location: Princeton, New Jersey (On-site)
Job Summary: We are searching for quality-focused professionals to support both commercial and development pharmaceutical programs. Our team is committed to ensuring exceptional compliance with current Good Manufacturing Practices, regulatory standards, and consistent delivery of high-caliber product quality solutions.
Responsibilities:
- Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs, and change controls adhere to quality system requirements and current GMP expectations.
- Review API, drug product, and packaging batch records, as well as test methods, specifications, validation protocols/reports, BOM, stability protocols and reports, and data within various electronic systems.
- Coordinate operational quality assurance through engagement with external CDMOs and laboratories, supporting quality event review, change controls, data verification, and batch record documentation processes.
- Represent quality on cross-functional project teams; support inspection readiness, regulatory submissions, continuous improvement initiatives, and timely review and release of clinical and commercial lots to maintain uninterrupted supply.
Required:
- Bachelor’s degree in a scientific discipline (such as Chemistry, Biology, Pharmacy, Engineering), or equivalent experience in a GMP-regulated environment.
- 4 to 7 years of experience within pharmaceutical quality, engineering, production, or QC/analytical development functions.
- Clear and technically accurate documentation skills, with the ability to review and provide feedback on GMP documents including SOPs, deviations, CAPAs, investigations, protocols, and reports.
- Demonstrated working knowledge of ICH guidelines (such as Q7/Q8/Q9/Q10, Q12), 21 CFR Parts 210/211 and/or EU GMPs, and proficiency with electronic QMS/eDMS systems; experience with at least two QMS elements such as deviation, CAPA, and change control is required.
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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