Senior QA Specialist: Validation, Investigations & NPI Lead

Cis-International-LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen in Juncos, PR seeks a senior QA professional to support the Quality Assurance program, review and approve product MPs, and lead cross-functional investigations.

Responsibilities include on-site release of validated processes, environmental characterization, incident triage, and QA representation on NPI teams, with a 12-month contract and possible extension based on performance and budget.

Qualifications

• Experience with commissioning and qualification, equipment validation.
• Knowledge of QRAES, Kneat, Good Documentation Practices, Change Controls, SOPs.
• Demonstrated interaction with regulatory agencies.
• Strong project management and cross-functional leadership.
• Ability to lead investigations and own site quality program procedures.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

Project management

Cross-functional leadership

Negotiation skills

QA knowledge

Regulatory interaction

Documentation & data analysis

Process development

Communication skills

Independent work

Data trending

Compliance evaluation

Amgen values

Education

Doctorate

Masters

Bachelors

Associates

High school/GED

Job description

Amgen in Juncos, PR seeks a senior QA professional to support the Quality Assurance program, review and approve product MPs, and lead cross-functional investigations.

Responsibilities include on-site release of validated processes, environmental characterization, incident triage, and QA representation on NPI teams, with a 12-month contract and possible extension based on performance and budget.