Senior GMP Materials Traceability and Manufacturing Operations Consultant

Weil Group, Inc; Manatí (PR); Hybrid; USD 100,000 - 150,000; Full time

Job summary

Weil Group Inc. is seeking a Senior GMP Materials Traceability and Manufacturing Operations Consultant for a project-based quality-system assessment in Manatí, Puerto Rico.

The consultant will reconstruct material movement and product identity across the manufacturing lifecycle, ensuring consistency of quantities and status. You will trace lots, reconcile genealogy and status, and propose practical improvements in traceability controls.

Qualifications

• Hands-on GMP materials and operations experience from receipt through consumption.
• Forward/backward genealogy reconstruction between supplier lots, internal materials, intermediates and finished batches.
• Evaluate status control, segregation, dispensing and quantity reconciliation.

Responsibilities

• Trace lots backward and materials forward through receipt, warehousing, dispensing, manufacturing, packaging and disposition.
• Reconcile material quantities, status, genealogy and equipment/record linkages.
• Identify improvements in segregation, hand-offs, reconciliation and traceability controls.

Skills

GMP materials & operations

material genealogy reconstruction

on-site operations

technical documentation

Education

Engineering or life sciences or quality or supply chain

Tools

Quality management systems (QMS)

LIMS

Job description

Senior GMP Materials Traceability and Manufacturing Operations Consultant

• Manati, PR
• Biotech/Pharmaceutical

Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation.

Reconstruct the physical and documented movement of materials and product and determine whether identity, quantities and status remain consistent throughout manufacturing.

What you will do

• Trace selected lots backward and selected materials forward through receipt, warehousing, dispensing, manufacturing, packaging and disposition.
• Reconcile material quantities, status, genealogy and relevant equipment or record linkages.
• Identify practical improvements in segregation, hand-offs, reconciliation and traceability controls.

Mandatory requirements

• Hands-on pharmaceutical or biologics GMP materials and operations experience from receipt and acceptance through consumption and finished product.
• Demonstrated forward and backward genealogy reconstruction between supplier lots, internal materials, intermediates and finished batches.
• Experience evaluating status control, segregation, dispensing and quantity reconciliation.
• Ability to connect materials and operations with batch records, relevant equipment, labeling and Quality decisions.
• Practical on-site experience following real operations and their associated records.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Evaluate yields, units, losses, returns, rejected materials, splits, blends and reprocessing where applicable.
• Map processes and develop workable manual and system controls based on demonstrated gaps.
• Relevant education in engineering, life sciences, quality or supply chain, or equivalent GMP operations experience.

Desired qualifications

• Experience with the confirmed product technology and materials-management systems.
• Traceability exercises supporting investigations or product recalls.
• Complex genealogy, sensitive materials or cold-chain operations where relevant.

**Weil Group is proud to be an Equal Employment Opportunity Employer.**