Job Title: Quality Control Scientist
Location: Westborough, Massachusetts (On-Site)
Job Summary: We invite driven professionals to be part of our team supporting a cGMP manufacturing environment. Our team is responsible for executing and troubleshooting laboratory methods and driving continuous improvement across critical quality operations.
Responsibilities:
- Perform and troubleshoot raw material laboratory testing, ensuring procedures follow both internal guidelines and external standards (USP, Ph.Eur., JP).
- Design and execute testing activities related to method transfer, validation, qualification, and verification, as well as participate in deviation and OOS investigations.
- Review and interpret test data, authorize quality control results, and participate in continuous improvement and best practice sharing with network sites.
- Support daily QC laboratory operations, including sample management, reagent preparation, instrument maintenance, and mentoring junior team members.
Required:
- B.S. degree in chemistry, biological sciences, or a related field with at least 6 years of relevant GMP Quality Control experience, or M.S. with at least 4 years of experience.
- Hands-on laboratory experience with techniques such as FTIR, Raman, Near-IR, HPLC analysis, and compendial assays.
- Technical expertise in 21CFR, ICH, USP, Ph. Eur., FDA guidance documents, and cGXPs, with proven knowledge in cGMP raw material program requirements.
- Strong data integrity and regulatory compliance understanding, proven ability to analyze experimental data, and proficiency with LIMS as an end user.
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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