QC Scientist, Raw Materials (GMP)

SGS Consulting; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS Consulting is seeking a QC Scientist I Raw Materials to execute and troubleshoot a variety of laboratory test methods in a GMP setting, ensuring data integrity and timely release testing. The role requires collaboration across teams, review of data, and support for method development and OOS investigations.

You will also mentor junior staff and share best practices across network sites to uphold quality standards and regulatory compliance.

Qualifications

• B.S. degree in chemistry, biological sciences or related field with 6+ years of GMP QC experience.
• M.S. degree with 4+ years of GMP QC experience.
• Experience with FTIR, Raman, Near-IR, HPLC and compendial assays.
• Strong knowledge of 21 CFR, ICH, USP, Ph. Eur. and FDA guidance; cGMP support.
• Excellent technical writing and verbal communication skills.

Responsibilities

• Develop/author/revise technical reports and laboratory procedures (SOPs, methods).
• Execute and troubleshoot raw material testing in support of production activities.
• Perform routine release sampling and testing of raw materials per compendial methods (USP, Ph.Eur., JP) and cGMP.
• Design and perform testing in support of method transfer/validation/qualification/verification.
• Review/authorize data and interpret test results and trends.
• Design and participate in method development; equipment qualification/validation; deviation and OOS investigations.
• Perform QC lab support activities including sample management, reagent preparation, instrumentation maintenance, and calibration.
• Support and mentor junior team members.
• Collaborate with other network sites to share best practices.
• Other duties as required.

Skills

Laboratory testing

Data analysis

Written communication

Team collaboration

GMP knowledge

Education

B.S. in chemistry or biological sciences (6+ years)

M.S. in chemistry or related field (4+ years)

Tools

FTIR

Raman

Near-IR

HPLC

LIMS

Job description

SGS Consulting is seeking a QC Scientist I Raw Materials to execute and troubleshoot a variety of laboratory test methods in a GMP setting, ensuring data integrity and timely release testing. The role requires collaboration across teams, review of data, and support for method development and OOS investigations.

You will also mentor junior staff and share best practices across network sites to uphold quality standards and regulatory compliance.