Specialist Quality Assurance - Drug Product

We are seeking a Specialist Quality Assurance to support the Drug Product Quality Assurance technical team at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. Working under minimal supervision, this role provides Quality oversight of manufacturing, packaging and inspection operations, ensuring compliance with cGMP and site quality procedures.

Key Responsibilities

• Review and approve master production records, process validation protocols and reports.
• Represent Quality on incident triage teams and New Product Introduction (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.

Requirements

• Education (one of the following)
• Doctorate degree; OR
• Master's degree + 2 years of directly related experience; OR
• Bachelor's degree + 4 years of directly related experience; OR
• Associate's degree + 8 years of directly related experience; OR
• High school diploma/GED + 10 years of directly related experience

Preferred Qualifications

• GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports and procedures
• Experience supporting packaging and/or inspection operations
• Strong knowledge of Good Documentation Practices (GDP) and electronic quality systems
• Ability to collaborate effectively with Manufacturing, Engineering and Process Development
• Bilingual English/Spanish communication skills