JT623 – SPECIALIST QA

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:  

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.

Demonstrate ability to interact with regulatory agencies.

Approve NC investigations and CAPA records.

Approve change controls.

Provide lot disposition and authorize lots for shipment.

Qualifications:

Bachelors degree in Sciences or Engineering

5 years of directly related experience

Knowledge of Deviations (Non-conformities, CAPA, and Change Control).

Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.

Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.

Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications.

Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.

Strong communication (both written and oral), facilitation and presentation skills.

Fully Bilingual in English and Spanish.

Available for Administrative shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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