Senior QC Laboratory Data Integrity Consultant

Weil Group, Inc; Manatí (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Weil Group Inc. is seeking a Senior QC Laboratory Data Integrity Consultant to assess pharmaceutical manufacturing quality-system data integrity on-site in Manatí, Puerto Rico.

The engagement centers on reviewing laboratory records, processing histories, metadata and audit trails to support quality decisions. The role involves tracing sample identities between instruments, LIMS and release packages, evaluating OOS handling, and delivering practical data-integrity controls to strengthen batch

Qualifications

• Hands-on pharmaceutical 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.

Responsibilities

• 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.

Skills

Data integrity

QC laboratory audit

Data review

LIMS knowledge

Documentation

English technical

Education

Laboratory science degree

Tools

LIMS

Laboratory instrumentation

Job description

Senior QC Laboratory Data Integrity Consultant

• Manati, PR
• Biotech/Pharmaceutical

Weil Group Inc. is identifying specialists for potential assignments within a proposed pharmaceutical manufacturing quality-system assessment. This opportunity is subject to confirmed specialist scope, project award and client confirmation.

Assess laboratory records and data histories that support Quality decisions and batch disposition when the project requires specialist laboratory expertise.

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.

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