Specialist QA 35657

Required Skills:

The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review documentation compliance electronic systems management inventory control and timely operational decision-making. The role requires a strong understanding of GMP requirements the ability to manage multiple priorities in a fast-paced manufacturing environment and the capability to work independently with minimal supervision. The ideal candidate demonstrates strong judgment effective communication attention to detail and the ability to clearly communicate critical information to cross-functional teams and management. Key Responsibilities 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. Core Qualifications & Competencies Technical 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 Leadership & Operational 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. Communication 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 Preferred Candidate Profile A results-driven professional with experience in GMP-regulated pharmaceutical or biotechnology manufacturing capable of combining Quality compliance operational knowledge electronic systems expertise and sound judgment.

Required Education:

Doctorate OR Masters 2 years of directly related experience OR -Bachelors 4 years of directly related experience Available to work 5:00 PM to 5:30Am