Regulatory QA & Inspection Specialist II

Avecia Pharma; Milford (MA); Sur place; USD 72 000 - 88 000; Plein temps

Résumé du poste

Avecia Pharma is seeking a Quality Assurance Compliance Specialist II to support regulatory intelligence and auditing within the Quality organization. Responsibilities include inspection readiness, audits, CAPA management, and KPI data compilation.

The role requires 5+ years in a regulated/GMP setting, deep knowledge of cGMP/FDA guidance, and strong leadership and documentation skills to drive timely corrective actions.

Qualifications

• At least 5 years’ experience in a regulated/GMP industry.
• Regulatory inspection experience to lead inspection readiness.
• Knowledge of cGMP, FDA regulations, USP/IcH guidance; interpretation and implementation.
• Proficient with PC-based word processors and spreadsheets.
• Proficient with electronic quality management systems (eQMS).
• Intermediate understanding of ICH, ISO, cGMP, USP, EU regulatory guidance.
• Ability to work in a fast-paced environment with minimal oversight.
• Strong leadership, written communication, and KPI development abilities.
• Experience with cross-functional collaboration across departments.

Responsabilités

• Support inspection administration during Health Authority and client inspections.
• Support audits and CAPA management to identify risks and ensure timely closure.
• Organize and manage quality documents, records, and data for audit readiness.
• Assist in preparing responses to inspectional observations.
• Monitor CAPAs and track KPI data for quality reviews.
• Maintain Site Master File and issue Letters of Authorization.
• Support internal audits to identify risks and report findings.

Connaissances

Regulatory inspection

cGMP knowledge

FDA regulations

Quality systems

ICH guidance

eQMS

Documentation

Leadership

MS Word

MS Excel

Outils

MS Word

MS Excel

Description du poste

Avecia Pharma is seeking a Quality Assurance Compliance Specialist II to support regulatory intelligence and auditing within the Quality organization. Responsibilities include inspection readiness, audits, CAPA management, and KPI data compilation.

The role requires 5+ years in a regulated/GMP setting, deep knowledge of cGMP/FDA guidance, and strong leadership and documentation skills to drive timely corrective actions.