Specialist QA

PRPDG; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

PRPDG is seeking a qualified QA professional to support Quality Assurance in GMP-regulated drug manufacturing. The role involves performing batch record reviews, ensuring GDP data integrity, and maintaining compliant documentation under minimal supervision.

Responsibilities include using SAP for inventory activities, reviewing eBR/PAX documents, participating in DAI meetings, and escalating risks to protect product quality and patient safety.

Qualifications

• GMP-regulated pharmaceutical manufacturing experience preferred.
• Experience with GDP documentation, data integrity, and traceability.
• Knowledge of SAP and electronic batch record systems.
• Ability to communicate risks and decisions to cross-functional teams.
• Detail-oriented with strong ownership and accountability.

Responsibilities

• Perform comprehensive Batch Record Review for completeness and GMP compliance.
• Review manufacturing docs for GDP and data integrity.
• Utilize SAP for inventory verification and manufacturing support.
• Review PAX/eBR documentation and workflows.
• Participate in DAI and other quality forums to present issues and decisions.
• Assess operations and apply risk-based decision making; escalate when needed.
• Support quality events, discrepancies, and process concerns.
• Work under pressure while maintaining accuracy and prioritization.
• Own assigned responsibilities with minimal supervision.
• Collaborate with Quality, Manufacturing, Supply Chain, and other teams.
• Maintain clear cross-shift communication of risks and pending items.
• Organize complex information for management decisions.
• Identify potential issues and pursue continuous improvement.

Skills

Strong written and verbal comms

Cross-functional collaboration

Risk-based thinking

Attention to detail

Problem-solving

Ability to work under pressure

Ownership and accountability

Education

Doctorate OR Masters + 2 years of directly related experience

Bachelor's + 4 years of directly related experience

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

Job description

SUMMARY

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

FUNCTIONS

• 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.

REQUIREMENT

• Doctorate OR Masters + 2 years of directly related experience ORBachelors + 4 years of directly related experience
• 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.
• 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.
• 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
• 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.
• 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.
• Available to work 5:00 PM to 5:30Am