QA Specialist - Validation, Compliance & Audit Lead

Echo-Consulting-Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Echo Consulting Group is seeking QA professionals to support quality assurance activities in Juncos, Puerto Rico. The role involves reviewing MPs, approving validation protocols, and leading site QA initiatives under minimal supervision.

Responsibilities include representing QA on NPI teams, leading investigations, and ensuring release of sanitary utility systems, change controls, and CAPA records. A strong background in QA, regulatory interactions, and cross-functional collaboration is required.

Qualifications

• PhD/Master’s with at least 3 years’ related QA experience or an equivalent combo.
• Preferred: NPIs, Change Control, FATs, Validation, PPQs.
• Strong knowledge of QA, manufacturing, distribution processes and regulatory interactions.

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.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

QA/QC expertise

Documentation skills

Analytical thinking

Communication skills

Education

Doctorate or Master’s with 3+ years related experience

Bachelor’s with 5+ years related experience

Associate’s with 10 years related experience

High school diploma / GED with 12 years related experience

Job description

Echo Consulting Group is seeking QA professionals to support quality assurance activities in Juncos, Puerto Rico. The role involves reviewing MPs, approving validation protocols, and leading site QA initiatives under minimal supervision.

Responsibilities include representing QA on NPI teams, leading investigations, and ensuring release of sanitary utility systems, change controls, and CAPA records. A strong background in QA, regulatory interactions, and cross-functional collaboration is required.