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QC Method Qualification Development/Test - Empower

In Massachusetts / United States

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QC Method Qualification Development/Test - Empower   

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JOB TITLE:

QC Method Qualification Development/Test - Empower

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Lexington Massachusetts / United States

JOB DESCRIPTION:

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

Position Details

POSTED:

Jun 26, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865140883762

LOCATION:

Massachusetts / United States

CITY:

Lexington

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

QC Method Qualification Development/Test - Empower    Apply

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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


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