QA Specialist: Validation, Compliance & Process Leadership

Pinnaql, Inc.; Juncos (PR); Presencial; USD 65 000 - 110 000; Tempo integral

Resumo da oferta

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Specialist QA to support quality assurance programs in pharmaceutical, biotech, chemical, food, and medical devices contexts.

You will review MPs, approve validation protocols, lead investigations, and represent QA on NPI teams. The role requires strong project management, cross-functional leadership, and experience with regulatory audits.

Qualificações

• Advanced degree with direct QA/validation experience.
• Ability to lead cross-functional teams and manage projects.
• Experience with regulatory agencies and GMP compliance.
• Strong documentation, data analysis, and communication skills.

Responsabilidades

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Coordinate with incident triage team for QA input.
• Approve Environmental Characterization reports.
• Release 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.

Conhecimentos

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory knowledge

Documentation & data analysis

Formação académica

Doctorate

Masters + 2 years related experience

Bachelors + 4 years related experience

Descrição da oferta de emprego

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Specialist QA to support quality assurance programs in pharmaceutical, biotech, chemical, food, and medical devices contexts.

You will review MPs, approve validation protocols, lead investigations, and represent QA on NPI teams. The role requires strong project management, cross-functional leadership, and experience with regulatory audits.