Weil Group, Inc is hiring: Senior Investigation Writer in Barceloneta

Position Purpose

The Senior Investigator Writer provides comprehensive quality assurance support for pharmaceutical manufacturing operations, including resolution of corrective and preventive actions (CAPA), leading investigations, coordinating local change plans, supporting complaint investigations, and ensuring cGMP and company policy compliance throughout the manufacturing facility.

Key Responsibilities

Investigation & Documentation

• Execute exception reports, complaints, PQRs, and change plan coordination with trend monitoring systems
• Ensure full compliance with company operations policies, plant procedures, and regulatory requirements
• Lead investigations for exception events across manufacturing, laboratories (QC, incoming, microbiology), validation, stability, and complaints
• Provide consistent, thorough investigation documentation with timely resolution based on CAPA requirements

Quality Assurance Activities

• Conduct product quality complaint investigations in accordance with company policies and regulatory standards
• Perform laboratory investigations for out-of-specification results and trending analysis
• Provide technical support to plant users on Exception Events IT Systems
• Document and coordinate local change plan assessments with end users and functional areas

Performance & Compliance

• Generate periodic quality metrics for investigations, complaints, change plans, PQRs, and key performance indicators
• Support New Product processes as QA investigator writer and liaison between company and third-party manufacturers/contractors
• Provide support during internal and external regulatory inspections
• Serve as first point of contact for potential manufacturing floor events, defining immediate mitigation activities

Environmental Health & Safety

• Conform to EHS management system requirements and compliance obligations
• Promote continuous improvement and consider EHS aspects during design and change processes
• Comply with all EHS procedures including incident reporting, PPE usage, and waste management

Required Qualifications

Education & Experience

Option 1:

• Bachelor's degree in Science or Engineering (Biology or Chemistry preferred)
• Minimum 4 years experience in Quality or technical field within Pharmaceutical/Biotechnological industry

Technical Requirements

• Advanced knowledge of technical operations necessary for successful job performance
• Strong understanding of cGMP and safety regulations
• Prior experience with CAPA processes, including authoring and approving laboratory and manufacturing investigations
• Experience with quality systems (change management, risk management documentation preferred)

Skills & Competencies

• Effective verbal and written communication skills in bothEnglish and Spanish
• Strong interpersonal and communication abilities
• Excellent problem-solving capabilities
• Ability to manage multiple priorities simultaneously
• Technical writing and documentation expertise