Senior QA Specialist - GMP & Batch Records

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen in Juncos, PR seeks a QA professional to support Quality Assurance programs under minimal supervision, focusing on batch record review, GDP compliance, and electronic systems management.

Responsibilities include leading investigations, site audits, change controls, CAPA, and cross-functional collaboration to ensure product quality and patient safety in a GMP-regulated environment.

Qualifications

• Doctorate or Masters with directly related experience.
• Bachelor's degree with 4+ years of directly related experience.
• Associates with 8+ years of directly related experience.
• High school/GED with 10+ years of directly related experience.

Responsibilities

• Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
• Review manufacturing documentation for 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.

Skills

Batch Record Review

GMP / GDP Documentation

SAP Inventory Management

PAX / eBR

Data Integrity

Quality Systems

Inventory Reconciliation

Leadership & Collaboration

Risk Assessment

Communication Skills

Education

Doctorate or Masters

Bachelor's + 4 years

Associates + 8 years

High school/GED + 10 years

Tools

SAP

eBR Systems

Job description

Amgen in Juncos, PR seeks a QA professional to support Quality Assurance programs under minimal supervision, focusing on batch record review, GDP compliance, and electronic systems management.

Responsibilities include leading investigations, site audits, change controls, CAPA, and cross-functional collaboration to ensure product quality and patient safety in a GMP-regulated environment.