Senior QA Specialist: Validation, Investigations & NPI Lead

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Amgen seeks a technical QA specialist to support the Quality Assurance program at the Juncos, PR site. The role involves approving validation protocols, incident triage input, and characterization and release activities for utilities and processes.

The position requires extensive QA, validation, and regulatory interaction experience, with leadership responsibilities on cross-functional teams. Long-term on-site assessment with a potential contract extension is anticipated.

Qualifications

• Doctorate, Masters, Bachelors, Associate or High School with related experience per education list.
• Directly related experience counts for each education level as listed.
• Strong knowledge of validation, CGMP, and data integrity.
• Ability to interact with regulatory agencies.
• Experience in QA leadership, change control, and procedures.

Responsibilities

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

Skills

Project management

Cross-functional leadership

Team facilitation

Negotiation

Regulatory interaction

QA and validation

Data analysis

Process development

Documentation skills

Independent work

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

Amgen seeks a technical QA specialist to support the Quality Assurance program at the Juncos, PR site. The role involves approving validation protocols, incident triage input, and characterization and release activities for utilities and processes.

The position requires extensive QA, validation, and regulatory interaction experience, with leadership responsibilities on cross-functional teams. Long-term on-site assessment with a potential contract extension is anticipated.