I3 INFOTEK INC
Title:
Senior Specialist, GMP Operational Quality
Please make an application promptly if you are a good match for this role due to high levels of interest. Location:
Hybrid — Boston, MA (3 days onsite, flexible) Key Responsibilities
Support quality oversight for deviations, OOS/OOT investigations, and CAPA actions. Assist with change control assessment, implementation, and closure. Draft and revise Quality Agreements with CMOs/Suppliers. Represent Quality on cross-functional teams and support continuous improvement initiatives. Review executed batch records, release data, and GMP documents (including certificates of analysis). Apply technical knowledge to support batch disposition and product quality decisions. Requirements
Bachelor’s degree in scientific or allied health field (or equivalent). 3+ years of GMP operational QA experience (drug substance/product; small molecules; biologics/gene therapy/device a plus). Knowledge of cGMP regulations across product lifecycle. Experience in RCA, CAPA, and root-cause investigations. Strong communication and cross-functional collaboration skills. Ability to evaluate quality issues, apply risk-based decisions, and support fast-paced projects.
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Senior Specialist, GMP Operational Quality
Please make an application promptly if you are a good match for this role due to high levels of interest. Location:
Hybrid — Boston, MA (3 days onsite, flexible) Key Responsibilities
Support quality oversight for deviations, OOS/OOT investigations, and CAPA actions. Assist with change control assessment, implementation, and closure. Draft and revise Quality Agreements with CMOs/Suppliers. Represent Quality on cross-functional teams and support continuous improvement initiatives. Review executed batch records, release data, and GMP documents (including certificates of analysis). Apply technical knowledge to support batch disposition and product quality decisions. Requirements
Bachelor’s degree in scientific or allied health field (or equivalent). 3+ years of GMP operational QA experience (drug substance/product; small molecules; biologics/gene therapy/device a plus). Knowledge of cGMP regulations across product lifecycle. Experience in RCA, CAPA, and root-cause investigations. Strong communication and cross-functional collaboration skills. Ability to evaluate quality issues, apply risk-based decisions, and support fast-paced projects.
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