QA Specialist: Validation & Compliance Leader

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program under minimal supervision in our pharma and biotech focused operations in Puerto Rico.

You will review MPs, approve validation protocols, lead investigations, and coordinate site audits while ensuring regulatory alignment and efficient release of manufactured lots. The ideal candidate has advanced degrees (PhD or MS with relevant experience) and strong cross-functional leadership,

Qualifications

• Doctorate or
• Masters plus 2 years of related experience or
• Bachelors plus 4 years of related experience

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of 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.

Skills

Project management

Organizational skills

Cross-functional leadership

Communication skills

Regulatory interactions

QA processes

Documentation skills

Independent work

Data trending

Education

Doctorate

Masters + 2 years of directly related experience

Bachelors + 4 years of directly related experience

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program under minimal supervision in our pharma and biotech focused operations in Puerto Rico.

You will review MPs, approve validation protocols, lead investigations, and coordinate site audits while ensuring regulatory alignment and efficient release of manufactured lots. The ideal candidate has advanced degrees (PhD or MS with relevant experience) and strong cross-functional leadership,