Senior GMP Materials Traceability and Manufacturing Operations Consultant

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.

How to apply

Apply through this posting with your CV, relevant project examples, current location, availability for work in Manatí and proposed hourly or daily consulting rate. Assignment scope, duration and terms will be confirmed with selected consultants.

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