Specialist QA - 35657

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

mîrus Consulting Group, a Humacao-based provider of pharmaceutical and IT consulting services, seeks a Specialist QA to support Quality and Manufacturing operations. The role focuses on Batch Record Review, documentation compliance, and electronic systems management in a GMP environment.

The ideal candidate will have advanced degrees with relevant GMP/biotech experience, strong data integrity knowledge, and proven ability to communicate risks across cross-functional teams.

Qualifications

• Experience in GMP-regulated pharmaceutical or biotech manufacturing.
• Strong understanding of GDP documentation and data integrity.
• Proven ability to manage multiple priorities in fast-paced environments.
• Ability to communicate risks and decisions clearly to cross-functional teams.
• Experience with SAP for inventory and batch-related activities.
• Proficient in handling electronic batch records (eBR) systems.

Responsibilities

• Perform comprehensive Batch Record Review for completeness, accuracy, and compliance with GMP/GDP procedures.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory-related activities including material verification and reconciliation.
• Work with PAX/eBR systems to review and support electronic manufacturing documentation.
• Support DAI meetings by presenting information, identifying risks, and communicating pending items.
• Evaluate operations and escalate issues based on impact to product quality, compliance, or safety.
• Collaborate with Quality, Manufacturing, Supply Chain and other cross-functional teams.
• Communicate complex information clearly to management and other stakeholders.

Skills

Batch Record Review

GMP / GDP Documentation

Data Integrity principles

Manufacturing and Quality Systems

Quality event assessment

Decision-making under pressure

Cross-functional collaboration

Clear communication

Education

Doctorate degree in Science/Engineering/Pharmacy/Biotechnology

Master's degree with ≥2 years related experience

Bachelor's degree with ≥4 years related experience

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

Job description

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.

Candidates must be available to work 3rd shift and non-standard work schedules as required.

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.

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.