QRC Group, Inc
Pharmaceutical, Medical Devices and Chemical Industries
SpecialistQA
“Specialist QA at QRC Group, Inc. Skills: NPI, Change Control, Validation, PPQs. Review and approve product MPs. Approve process validation protocols”
What You'll Achieve.
Provide lot disposition; Authorize lots for shipment
Industry & Context.
Lead investigations
What They're Looking For.
Must Have
Doctorate or Master's Degree and 2 years of experience of Quality Manufacturing support, Bachelor's Degree and 4 years of experience of Quality Manufacturing support, Associate Degree and 8 years of experience of Quality or Manufacturing support, Educational background in Life Sciences and/or Engineering, Expertise in NPI, Expertise in Change Control, Expertise in FATs, Expertise in Validation, Expertise in PPQs, Bilingual (English and Spanish)
What You'll Do.
Review and approve product MPs
Approve process validation protocols
Approve process validation reports
Request Quality on incident triage team
Approve Environmental Characterization reports
Release of sanitary utility systems
Approve planned incidents
Represent QA on NPI team
Own site quality program procedures
Designee for QA manager on local CCRB
Review Risk Assessments
Support Automation activities
Support facilities programs
Support environmental programs
Review and approve Work Orders
Review and approve EMSMS alarms
Approve NC investigations
Approve change controls
Provide lot disposition
Authorize lots for shipment
How You'll Work.
Team & Collaboration
Represent QA on NPI team; Designee for QA manager on local CCRB
Communication Scope
Bilingual (English and Spanish)
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