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Sr. QC Specifications Analyst

Company: MacroGenics, Inc.
Location: Rockville
Posted on: September 17, 2021

Job Description:

Our Client, a BioPharmecutical manufacturing company located in Rockville, MD, is looking to bring on an experienced QC Analyst to their team. This person will be responsible for creating and revising specifications using established procedures and the GMP change control system, ensuring all changes are recorded and completed correctly and all supporting documentation is gathered and maintained [manufacturer drawings, vendor certificates of analyses (COAs), result reports, etc.]. They will also be responsible for monitoring compendia and other guidance documents (USP/NF, Ph. Eur., BP, JP, ChP, ACS, and FCC as needed) and creating and updating risk assessments in the electronic Document Management System (MasterControl) for raw materials.

Experience in a Pharmaceutical company

Experience with specifications testing, analysis, and change control

Experience implementing, validating, utilizing and maintaining LIMS (particularly LabVantage)

Experience with operational and document change control (particularly via SAP and MasterControl)

Relevant Project Management Institute (PMI) certification

Degree in a science or quality related field
Bachelors or Associates Degree

6+ years of experience as a Quality professional in the Bio/Pharm industry

o QA, QC, or Raw Materials

Working knowledge of and experience with standard concepts, practices and procedures within Quality Control and working in a GMP or GLP testing environment

Keywords: MacroGenics, Inc., Rockville , Sr. QC Specifications Analyst, Other , Rockville, Maryland

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