QC Analyst I – Analytical for Raw Materials (cGMP)

RoslinCT US

Hopkinton (MA)

On-site

USD 55,000 - 75,000

Full time

4 days ago

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Job summary

RoslinCT US is seeking a Quality Control Raw Material Analyst to perform QC inspection and sampling of incoming materials, author specifications, and conduct routine cGMP testing. The role supports technology transfer and method qualification, while ensuring compliance with quality systems and regulatory requirements.

The candidate will work with analytical teams, document SOPs, and participate in audits, investigations, and CAPAs.

Qualifications

Bachelor's degree in a scientific discipline is required.
0-2+ years of relevant raw material QC lab experience in a cGMP setting.
Knowledge of cGMP/ICH/FDA regulations.
Ability to independently prioritize and manage multiple projects and timelines.
Experience with MS Office and LIMS for documentation and data management.
Strong troubleshooting and communication skills, both written and oral.

Responsibilities

Perform QC inspection and sampling of incoming raw materials and packaging components.
Author material specifications or SOPs to support Raw Material Program.
Perform routine and non-routine QC testing on raw materials, in-process samples, and finished products.
Ensure calibration and maintenance of laboratory equipment; support 21 CFR Part 11 compliance.
Collaborate with cross-functional teams and participate in internal/external audits and CAPAs.