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Specialist QA - 35657
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
The Specialist QA 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.
Education
• Doctorate degree in Science, Engineering, Pharmacy, Biotechnology, or a related field; OR
• Master's degree with a minimum of two (2) years of directly related experience; OR
• Bachelor's degree with a minimum of four (4) years of directly related experience.
• 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.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
Position Summary
The Specialist QA 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.
Education
• Doctorate degree in Science, Engineering, Pharmacy, Biotechnology, or a related field; OR
• Master's degree with a minimum of two (2) years of directly related experience; OR
• Bachelor's degree with a minimum of four (4) years of directly related experience.
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Candidates must be available to work 3rd shift and non-standard work schedules as required.
• 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.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.