Senior QA Specialist — cGMP & Compliance

Echo-Consulting-Group; Puerto Rico; Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Echo-Consulting-Group seeks experienced QA professionals to support cGMP processes, batch record review, and quality system maintenance. The role involves on-the-floor QA reviews, CAPAs, deviations, and collaboration across Manufacturing, Validation, and Regulatory teams.

Ideal candidates hold advanced degrees with relevant experience, excellent English communication, and the ability to work with diverse stakeholders in a fast-paced pharmaceutical environment. Location: Juncos, PR; on-site.

Qualifikationen

• Doctorate or Master’s degree with 3+ years of directly related experience, or a Bachelor’s with 5+ years of related experience.
• Fluent in English; Spanish language skills beneficial for collaboration with diverse teams.

Aufgaben

• Perform on-the-floor QA review, approval, and tracking of cGMP processes and batch records.
• Support internal/external audits and inspections as part of the QA/inspection team.
• Lead continuous improvement initiatives and cross-functional projects.

Kenntnisse

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory liaison

Documentation skills

QA & Validation

Process development

Data trending

Compliance evaluation

Leadership presence

Ausbildung

Doctorate or Master’s with 3+ years related experience

Tools

MS Office

Jobbeschreibung

Echo-Consulting-Group seeks experienced QA professionals to support cGMP processes, batch record review, and quality system maintenance. The role involves on-the-floor QA reviews, CAPAs, deviations, and collaboration across Manufacturing, Validation, and Regulatory teams.

Ideal candidates hold advanced degrees with relevant experience, excellent English communication, and the ability to work with diverse stakeholders in a fast-paced pharmaceutical environment. Location: Juncos, PR; on-site.