Senior QA Specialist: Process Validation & Compliance

Weil Group, Inc; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

Weil Group, Inc. is seeking a Senior QA professional to act as a technical specialist in support of the Quality Assurance program. The role requires reviewing and approving product MPs, leading investigations, and owning site quality procedures to ensure compliance.

The position involves representing QA on cross-functional teams, coordinating regulatory interactions, and maintaining robust quality systems across manufacturing and distribution processes at the Juncos, PR site.

Qualifications

• Minimum education as listed: Doctorate with related experience or Master’s with related experience or Bachelor’s with extensive experience or Associate’s with longer experience or high school diploma with extended experience.

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

Organizational skills

Leadership and negotiation

Regulatory interaction

Documentation and data analysis

Communication and presentation

Independent working

Data trending and evaluation

Education

Bachelor's degree or higher in a related field

Job description

Weil Group, Inc. is seeking a Senior QA professional to act as a technical specialist in support of the Quality Assurance program. The role requires reviewing and approving product MPs, leading investigations, and owning site quality procedures to ensure compliance.

The position involves representing QA on cross-functional teams, coordinating regulatory interactions, and maintaining robust quality systems across manufacturing and distribution processes at the Juncos, PR site.