Specialist QA 35657

Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Non Standar Shift (Available to work 5:00 PM to 5:30 AM) Job Description: Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities . Requirements & Qualifications: Batch Record Review GMP / GDP Documentation SAP Inventory Management PAX / Electronic Batch Records (eBR) Manufacturing and Quality Systems Inventory reconciliation and material traceability Quality event assessment and escalation Data Integrity principles Sound decision-making Risk-based thinking Ability to work under pressure Ability to work with minimal supervision Strong ownership and accountability Effective prioritization and time management Problem-solving skills Cross-functional collaboration. Strong written and verbal communication skills Ability to present information during DAI and operational meetings Clear communication of risks, priorities, pending items, and decisions Ability to translate complex operational information into concise, actionable messages for different levels of the organization Functions: Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements. Review manufacturing documentation for Good Documentation Practices (GDP), data integrity, accuracy, traceability, and procedural compliance. Utilize SAP for inventory-related activities, including material verification, inventory transactions, reconciliation, status review, and manufacturing support. Demonstrate experience with PAX / Electronic Batch Record (eBR) systems to review, assess, and support electronic manufacturing documentation and workflows. Participate actively in DAI meetings and other operational or Quality forums by presenting relevant information, identifying risks, communicating pending items, and supporting timely decisions. Evaluate operational situations and apply appropriate decision-making and risk-based thinking, escalating issues when required based on potential impact to product quality, compliance, operations, or patient safety. Support the assessment and communication of Quality events, documentation discrepancies, process concerns, and operational issues. Work effectively under pressure while maintaining accuracy, compliance, and appropriate prioritization of critical activities. Manage assigned responsibilities independently and with minimal supervision, demonstrating ownership, accountability, and appropriate follow-through. Collaborate effectively with Quality, Manufacturing, Supply Chain, Warehouse, and other cross-functional teams. Maintain strong communication across shifts and functions to ensure critical information, pending activities, risks, and decisions are clearly transferred. Organize complex information and communicate it clearly, concisely, and accurately, enabling management and cross-functional teams to make informed decisions. Identify potential issues proactively and demonstrate a solution-oriented and continuous-improvement mindset. Education Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience