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Specialist QA chez QRC Group, Inc

QRC Group, Inc · Juncos, États-Unis d'Amérique · Onsite

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Company 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!

Job Description:

We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection, warehouse floor audits, and deviation management. The ideal candidate will bring technical expertise, digital fluency, and a strong understanding of regulated environments.

Primary Focus Areas

• Perform sampling and inspection of incoming materials and components.

• Conduct quality audits of warehouse floor operations to ensure compliance with SOPs and GMP standards.

• Initiate, investigate, and approve quality deviations (non-conformances) in coordination with cross-functional teams.

• Utilize Smartsheet, Power BI, SAP, and Generative AI tools to manage quality data, reporting, and workflows.

Additional Responsibilities 

• Review and approve Master Production Records (MPs) and process validation protocols/reports.

• Represent QA on New Product Introduction (NPI) teams and incident triage groups.

• Approve Environmental Characterization reports and release sanitary utility systems.

• Lead investigations and site audits; own site-level quality program procedures.

• Act as designer for QA Manager on local Change Control Review Board (CCRB).

• Review risk assessments, work orders, EMS/BMS alarms, and planned incidents.

• Approve NC investigations, CAPA records, and change controls.

• Provide lot disposition and authorize product lots for shipment.

• Support automation, facilities, and environmental compliance programs.

Qualifications:

Education in a relevant scientific or engineering discipline:

-Doctorate or Masters + 2 years of directly related experience or

-Bachelors + 4 years of directly related experience 

Shift

- Available for 3rd shit and Non-Standard Shift.

Additional Information:

All your information will be kept confidential according to EEO guidelines.

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