QA Specialist - cGMP Biopharma | On-Site PR

Biopharma-Consulting-Jad-Group; Juncos (PR); Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a Specialist Quality Assurance to support the Drug Product QA team at our biopharmaceutical site. The role provides quality oversight of manufacturing, packaging, and inspection operations to ensure compliance with cGMP and site procedures.

Under minimal supervision, you will review records, lead investigations, support risk assessments, and coordinate with Manufacturing, Engineering and Process Development.

Qualifications

• Education options include Doctorate, or Master’s with related experience, or Bachelor's with related experience, or Associate's with related experience, or HS diploma with related experience.

Responsabilités

• Review and approve master production records, process validation protocols and reports.
• Represent Quality on incident triage teams and NPI teams.
• Approve change controls, planned incidents, nonconformance investigations and CAPA records.
• Lead investigations and site audits; own site quality program procedures.
• Review risk assessments and support automation, facilities and environmental programs.
• Review and approve work orders and EMS/BMS alarms; approve environmental characterization reports and release of sanitary utility systems.
• Act as designee for the QA manager on the local change control review board.
• Provide lot disposition and authorize lots for shipment.

Connaissances

Project management

Quality oversight

Regulatory compliance

Data trending

Communication

Formation

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Outils

GDP knowledge

Electronic quality systems

Microsoft Office

Description du poste

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a Specialist Quality Assurance to support the Drug Product QA team at our biopharmaceutical site. The role provides quality oversight of manufacturing, packaging, and inspection operations to ensure compliance with cGMP and site procedures.

Under minimal supervision, you will review records, lead investigations, support risk assessments, and coordinate with Manufacturing, Engineering and Process Development.