QA Specialist: Validation, Audits & CAPA

Validation-; Juncos (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support Quality Assurance programs with minimal supervision. The role covers review/approval of MPs, validation protocols, environmental reports, incident triage, and site quality management.

The ideal candidate will lead investigations, audits, and cross-functional teams, with strong regulatory interaction skills and a solid background in QA, validation and process development.

Qualifications

• Pharma/biotech QA/validation experience.
• Strong knowledge of QA, QAL, validation and process development.
• Experience interacting with regulatory agencies.
• Ability to lead investigations and audits.
• Experience with CAPA, change controls and risk assessments.

Responsabilités

• Review and approve MPs and validation protocols.
• Approve environmental characterization and sanitary utility releases.
• Lead site audits and investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Connaissances

Project management

Cross-functional leadership

QA & Validation

Regulatory interactions

Data trending

Communication skills

Independent work

Formation

Doctorate

Masters + 2 years of related experience

Bachelors + 4 years of related experience

Description du poste

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support Quality Assurance programs with minimal supervision. The role covers review/approval of MPs, validation protocols, environmental reports, incident triage, and site quality management.

The ideal candidate will lead investigations, audits, and cross-functional teams, with strong regulatory interaction skills and a solid background in QA, validation and process development.