Senior QA Specialist - Batch Records & Compliance

Cis-International-LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Amgen in Juncos, PR seeks a QA professional to support the Quality Assurance program with minimal supervision. Responsibilities include batch record review, GDP documentation, and release of manufacturing documentation; use SAP and eBR systems; participate in QA investigations and site audits.

The role requires strong communication, risk-based thinking, and the ability to work cross-functionally with Manufacturing, Supply Chain, and QC teams.

Qualifications

• The position emphasizes Batch Record Review and GMP-compliant documentation.
• Experience with GDP and data integrity is expected.

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

Manufacturing & Quality Systems

Inventory reconciliation

Quality event assessment

Data Integrity

Leadership & Operations

Decision making under pressure

Cross-functional collaboration

Communication skills

Documentation & tracing

Regulatory interaction

Education

Doctorate or Masters + 2 years of directly related experience

Bachelors + 4 years of directly related experience

Associates + 8 years of directly related experience

High school/GED + 10 years of directly related experience

Tools

SAP

PAX

eBR

Job description

Amgen in Juncos, PR seeks a QA professional to support the Quality Assurance program with minimal supervision. Responsibilities include batch record review, GDP documentation, and release of manufacturing documentation; use SAP and eBR systems; participate in QA investigations and site audits.

The role requires strong communication, risk-based thinking, and the ability to work cross-functionally with Manufacturing, Supply Chain, and QC teams.