QA Specialist – Onsite NPI & Change Control Lead

ProQualityNetwork; Juncos (PR); Presencial; USD 60 000 - 90 000; Tempo integral

Resumo da oferta

ProQualityNetwork in Juncos, Puerto Rico, seeks a QA professional to support the client's QA program on-site for a 3-month contract. You will review MPs, validation protocols, and CAPA, while representing QA on the NPI team and leading investigations.

The role requires strong leadership, cross-functional collaboration, and experience in manufacturing QA, regulatory interfaces, and risk assessments. Availability for multiple shifts onsite is required, with a focus on quality assurance and

Qualificações

• Candidates must meet one of the education/experience options.
• Experience in QA, validation, and manufacturing environment.
• Proven ability to lead cross-functional teams.

Responsabilidades

• Review and approve MPs.
• Review and approve validation protocols and reports for manufacturing processes.
• Serve as a QA representative on the Incident Triage Team.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on the New Product Introduction (NPI) team.
• Lead investigations and site audits.
• Own and maintain site Quality program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Review risk assessments.
• Support automation-related activities, facilities programs, and environmental programs.
• Review and approve EMS and BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Determine lot disposition and authorize lots for shipment.

Conhecimentos

Project management

Cross-functional leadership

QA knowledge

Validation planning

Change control

Regulatory liaison

Data trending

Communication

Independent work

Formação académica

Master's degree

Bachelor's degree

Associate degree

High school diploma

Descrição da oferta de emprego

ProQualityNetwork in Juncos, Puerto Rico, seeks a QA professional to support the client's QA program on-site for a 3-month contract. You will review MPs, validation protocols, and CAPA, while representing QA on the NPI team and leading investigations.

The role requires strong leadership, cross-functional collaboration, and experience in manufacturing QA, regulatory interfaces, and risk assessments. Availability for multiple shifts onsite is required, with a focus on quality assurance and