Biopharma QA Specialist - Quality & Compliance (Contract)

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 39,000 - 50,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Specialist Quality Assurance to support the Drug Product Quality Assurance team at a manufacturing site in Juncos, Puerto Rico. The role provides QA oversight of manufacturing, packaging and inspection operations to ensure cGMP compliance and adherence to site procedures.

Key responsibilities include approving master production records, change controls, deviations, CAPAs, and leading site audits.

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.

Job description

BioPharma Consulting JAD Group seeks a Specialist Quality Assurance to support the Drug Product Quality Assurance team at a manufacturing site in Juncos, Puerto Rico. The role provides QA oversight of manufacturing, packaging and inspection operations to ensure cGMP compliance and adherence to site procedures.

Key responsibilities include approving master production records, change controls, deviations, CAPAs, and leading site audits.