Quality Control Manager
Company: VirtualVocations
Location: Indianapolis
Posted on: February 4, 2025
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Job Description:
A company is looking for a Senior Manager, Quality Control to
lead Quality Control activities for a late-stage small molecule
oncology program.
Key Responsibilities:
Collaborate with internal teams and external partners to assemble
data packages for shelf-life extensions and method changes
Conduct QC reviews of analytical release and stability data,
ensuring accuracy and compliance with specifications
Investigate and resolve analytical test failures in collaboration
with cross-functional teams
Required Qualifications:
BS in chemistry or related discipline with at least 8 years of
relevant experience, or MS/PhD with 5+ years of experience,
including 2 years at the QC Manager level
Strong understanding of cGMP/ICH regulations and USP Guidelines
Knowledge of analytical testing concepts in small-molecule drug
development
Experience in authoring and reviewing regulatory documentation
Proficiency with JMP and statistical analysis concepts is
preferred
Keywords: VirtualVocations, Middletown , Quality Control Manager, Executive , Indianapolis, Ohio
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