QRC Group, Inc

Pharmaceutical, Medical Devices and Chemical Industries

SpecialistQA

Juncos, Puerto Rico CONTRACT
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for executive candidates.

The Brief

“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.

Pharmaceutical, Medical Devices and Chemical Industries
Problems you'll solve

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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