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.
Administrative Shift
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