Quality Record Investigation Lead Consultant

ProPharma Group; Chicago (IL); Hybrid; USD 110,000 - 150,000; Full time

Job summary

ProPharma Group is seeking a Quality Record Investigation Lead Consultant to work on-site in Chicago, IL. The role focuses on reviewing, investigating, documenting, and closing low-risk non-conformances and batch-related records within a six-week window at the client facility.

Candidates should be proficient in independent work, project leadership, and regulatory documentation practices. The consultant will oversee execution, milestones, and delivery performance, interfacing with the client,

Qualifications

• Experience leading non-conformance investigations and closure
• Ability to review and close batch-related records
• Strong documentation and audit trail skills
• Experience reporting progress via KPI dashboards
• Comfortable working independently on-site at client site

Responsibilities

• Lead client interface and drive project execution onsite in Chicago
• Manage project milestones, timelines and deliverables
• Produce weekly status reports and escalate risks/issues
• Oversee team productivity and performance against KPIs
• Support investigation and closure of exceptions and non-conformances as needed

Skills

Project management

Investigation

Documentation

Batch records

KPI tracking

Risk escalation

Client interface

Job description

## Quality Record Investigation Lead ConsultantApply: United States: Full time: Posted Yesterday: JR 10853For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.Client is seeking support to review, investigate, document, and close low-risk non-conformance and batch-related records within a six-week timeframe at their facility in Chicago, IL. All work will be conducted on-site for this project. Consultant should have strong investigation, documentation, and batch record review/closure experience and be comfortable working independently within the client environment. This consultant will assume responsibility for overall execution, milestone management, and delivery performance. Primary duties will include: * Primary client interface* Project management and KPI tracking* Weekly status reporting* Risk and issue escalation* Team oversight and productivity management* Support execution of exception and non-conformance investigations and closures as needed