Senior QC Laboratory Data Integrity Consultant

What you will do

• Review original laboratory data, processing history, metadata and relevant audit trails.
• Trace sample and result identities between instruments, laboratory data systems, LIMS and the release package.
• Evaluate OOS or atypical-result handling and propose practical review controls.

Mandatory requirements

• Hands-on pharmaceutical or biologics QC laboratory record assessment.
• Experience reviewing original data, reprocessing histories, OOS or atypical results and Quality review.
• Ability to connect instrument or laboratory-system records with LIMS results and batch-disposition evidence.
• 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.
• Understand relevant analytical or microbiological workflows and data-system controls.
• Evaluate access, audit trails, sample identity, metadata and retention requirements applicable to laboratory records.
• Relevant laboratory science, chemistry, microbiology or quality education, or equivalent practical experience.

Desired qualifications

• Experience with the analytical methods and laboratory platforms included in the project.
• Chromatography or complex electronic laboratory-data expertise where relevant.
• Laboratory investigation or data-integrity improvement projects with implemented outcomes.

How to apply