Specialist QA - 35657

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a Specialist QA in Juncos, Puerto Rico to support GMP-compliant manufacturing operations. The role concentrates on batch record review, documentation compliance, and electronic systems management within SAP and eBR environments.

The successful candidate will manage multiple priorities, communicate risks clearly to cross-functional teams, and uphold data integrity and GDP standards in a fast-paced setting.

Qualifications

• Doctorate or Masters with related experience required
• Bachelor's degree with 4+ years of related experience required

Responsibilities

• Perform comprehensive Batch Record Review for completeness and GMP compliance
• Review manufacturing documentation for GDP, data integrity, traceability
• Utilize SAP for inventory verification and transactions
• Review and support eBR system documentation workflows
• Participate in DAI meetings presenting risks and pending items
• Assess operations and apply risk-based decision-making; escalate as needed
• Support assessment of Quality events and discrepancies
• Work under pressure while maintaining accuracy and prioritization
• Take ownership with minimal supervision; ensure follow-through
• Collaborate with Quality, Manufacturing, Supply Chain, Warehouse
• Maintain clear cross-shift communication of risks and decisions
• Organize information clearly for management to decide
• Identify potential issues and pursue continuous improvement

Skills

SAP Inventory Management

PAX / eBR

Manufacturing & Quality Systems

Inventory reconciliation

Data Integrity

Quality event assessment

Cross-functional collaboration

Risk-based thinking

Education

Doctorate or related

Masters + 2 years related experience

Bachelor's + 4 years related experience

Tools

SAP

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Specialist QA - 35657

Juncos, Puerto Rico | Posted on 09/03/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

The position 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.

Core Qualifications & Competencies

Technical

• 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.

Requirements

• Doctorate OR Masters + 2 years of directly related experience OR
• Bachelors + 4 years of directly related experience