QRC Group, Inc
Pharmaceutical, Medical Devices and Chemical Industries
SpecialistQA
Neural analysis suggests this role is
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“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)
Full Job Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com / to learn more about our services and solutions! Specialist QA with experience in regulated industry. Expertise in NPI, Change Control, FATs, Validation and PPQs. Duties: * Review and approve product MPs. * Approve process validation protocols and reports for manufacturing processes. * Request Quality on incident triage team. * Approve Environmental Characterization reports. * Release of sanitary utility systems. * Approve planned incidents. * Represent QA on NPI team. * Lead investigations. * Lead site audits. * Own site quality program procedures. * Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities. * Support facilities and environmental programs. * Review and approve Work Orders. * Review and approve EMS/BMS alarms. * Approve NC investigations and CAPA records. * Approve change controls. * Provide lot disposition and authorize lots for shipment. ## Qualifications * 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 or Associate Degree and 8 years of experience of Quality or Manufacturing support (Educational background in Life Sciences and/or Engineering). * Expertise in NPI, Change Control, FATs, Validation and PPQs * Bilingual (English and Spanish) ## Additional Information All your information will be kept confidential according to EEO guidelines.
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