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QC Method Qualification Development/Test - Empower Location: US-MA-Lexington Email this job to a friend
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Responsibilities: - Develop and testing of UPLC/Utilizing Empower Software
- Perform test method transfer, assay qualification, and troubleshooting.
- Work collaboratively with Upstream PD, Downstream PD, Analytics, and Research groups to develop an increased depth of knowledge of processes and identify improvement opportunities.
- Writes and develops method validation protocols, reports, and test methods.
Requirement: - BS and/or MS degree in biochemistry, cell biology, and/or molecular biology discipline.
- At least 6 years of work experience in a GMP environment.
- Previous experience Developing and testing of UPLC/HPLC Utilizing Empower Software
- Proven experience writing and developing method validation protocols, reports, and test methods.
- Strong knowledge of cGMP/ICH/FDA/EU regulations.
- Technology environment the consultant will be working in Empower Software
Katalyst HealthCares & Life Sciences Inc
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