QA Consultant for Drug Substance
Company: VirtualVocations
Location: Vista
Posted on: May 20, 2025
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Job Description:
A company is looking for a QA Consultant (Drug Substance) to
support early-phase programs and ensure compliance with GMP
regulations.
Key Responsibilities
Support QA systems and activities including change control,
deviation management, and quality risk management
Assist with CDMO lifecycle activities and collaborate with internal
teams to resolve quality issues
Contribute to CAPA and quality risk systems to ensure compliance
risk identification and support product release across various
jurisdictions
Required Qualifications
Bachelor's degree in a relevant field with 5-8 years of QA
experience focused on drug substance for early phase programs
Prior experience supporting API development, chemical synthesis,
and manufacturing
Strong background in reviewing DS and API documentation including
batch records and deviations
Ability to conduct audits and develop CAPAs while identifying root
causes and mitigating risks
In-depth knowledge of global GMP regulations and industry
standards
Keywords: VirtualVocations, Aliso Viejo , QA Consultant for Drug Substance, Professions , Vista, California
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