Investigation Specialist (CAPA & Deviations)

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

Investigation Specialist (CAPA & Deviations)

• Biotech/Pharmaceutical

Looking for an Investigation Specialist that manages deviation investigations for manufacturing, ensures compliance with GMP/FDA regulations, and oversees corrective actions.

• Ensure that all QE's, NTR's, NOE's and CAPA's are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
• Reviews and provides input to regulatory submissions applicable to area of responsibility.
• Leads QE's and CAPA's trend evaluation.
• Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
• Supports establishment of process monitoring parameters and control limits.
• Supports the assessment of deviations and process monitoring data
• Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.
• Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP's compliance.
• Write, evaluate and revise the required manufacturing documentation (i.e. SOP's, MBR's, etc.) and may assist in providing training on scientific or technical aspects of the processes.
• Assists with generation and execution of validation protocols and reports.
• Participate in regulatory inspection when necessary.
• Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity).
• Provides alternatives and recommendations to improve and maximize processes and equipment.
• Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
• Promote and model the Client Core Behaviours, facilitating teamwork.
• Supports all site Initiatives and any other assignments based on business needs.

Weil Group is proud to be an Equal Employment Opportunity Employer.