CAPA & Deviations Investigation Lead

Weil Group, Inc; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Weil Group, Inc. is seeking an Investigation Specialist (CAPA & Deviations) to manage deviation investigations for manufacturing and ensure GMP/FDA compliance. The role entails overseeing QE's, NTR's, NOE's and CAPA's within established timeframes while utilizing tools to prevent recurrence.

You will lead CAPA and QE trend evaluation, participate in regulatory submissions input, and support process improvements, documentation, and training. Collaborative and quality-focused environment.

Qualifications

• Experience managing deviation investigations in a GMP/FDA regulated environment.
• Strong understanding of CAPA process and regulatory requirements.
• Ability to analyze process data and implement effective corrective actions.

Responsibilities

• Manage deviation investigations for manufacturing and ensure timely closure of QE's, NTR's, NOE's and CAPA's.
• Lead CAPA and QE trend evaluation and participate in regulatory submissions input.
• Support new product introduction, documentation, training and equipment modifications.
• Provide technical guidance to optimize processes, yield, and productivity.
• Assist with validation protocols, regulatory inspections, and cross-functional problem solving.

Job description

Weil Group, Inc. is seeking an Investigation Specialist (CAPA & Deviations) to manage deviation investigations for manufacturing and ensure GMP/FDA compliance. The role entails overseeing QE's, NTR's, NOE's and CAPA's within established timeframes while utilizing tools to prevent recurrence.

You will lead CAPA and QE trend evaluation, participate in regulatory submissions input, and support process improvements, documentation, and training. Collaborative and quality-focused environment.