The Role
Support pharmaceutical manufacturing Quality and Manufacturing operations through batch record review, GMP/GDP documentation compliance, SAP inventory management, electronic batch record workflows, quality event assessment, risk-based decision-making, and cross-functional communication. The role reviews data integrity and traceability, escalates compliance and operational risks, participates in DAI meetings, maintains shift handoffs, and supports timely, accurate decisions in a regulated manufacturing environment.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Supporting Quality and Manufacturing operations through accurate Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational decision-making.
- 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.
Qualifications:
- Bachelor's Degree in related area
- Experience in GMP-regulated pharmaceutical or biotechnology manufacturing, capable of combining Quality compliance, operational knowledge, electronic systems expertise, and sound judgment.
- 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
- Risk-based thinking
- 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
Skills Required
- Bachelor's degree in a related area
- Experience in GMP-regulated pharmaceutical or biotechnology manufacturing
- Batch record review experience
- GMP and GDP documentation knowledge
- SAP inventory management experience
- PAX or Electronic Batch Record experience
- Manufacturing and Quality Systems experience
- Inventory reconciliation and material traceability experience
- Quality event assessment and escalation experience
- Knowledge of data integrity principles
- Risk-based thinking
- 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
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
