Quality Record Investigation Consultant

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Record Investigation Consultant based in the United States. Overview We are seeking a detail-oriented Quality Record Investigation Consultant to support quality and compliance activities within a regulated pharmaceutical or life sciences environment. In this role, you will review, investigate, document, and close low-risk non-conformance and batch-related records within a six-week project timeline. You will play a key role in maintaining accurate quality documentation and ensuring records are completed in accordance with established procedures. Working on-site at a client facility in Chicago, Illinois, you will operate independently while managing deliverables, milestones, and overall project execution. This opportunity is ideal for a quality professional with strong investigative skills, hands-on batch record experience, and a commitment to accuracy and regulatory compliance. Your contribution will help streamline quality processes and support operational excellence in a fast-paced, highly regulated environment. Accountabilities - Review quality records: Examine assigned records to verify accuracy, completeness, and consistency with applicable quality procedures and documentation standards. - Conduct investigations: Investigate low-risk non-conformances and batch-related issues, gathering relevant information and documenting findings clearly and accurately. - Manage documentation: Prepare and maintain thorough investigation records, ensuring that all required information is properly captured and traceable. - Drive record closure: Complete assigned record closure activities within the established project timeline, ensuring that documentation requirements are met.

- Manage project delivery: Take ownership of assigned activities, monitor milestones, and ensure timely and effective execution of responsibilities. - Escalate issues appropriately: Identify exceptions, unresolved discrepancies, and support needs, communicating them promptly to the relevant stakeholders. - Work independently: Operate effectively within the client’s on-site environment while maintaining productivity, quality standards, and accountability for deliverables. Requirements - Relevant experience: Demonstrated experience in quality investigations, non-conformance management, and quality record review and closure within a regulated pharmaceutical, biotechnology, medical device, or life sciences environment. - Batch record expertise: Proven hands-on experience reviewing batch records, identifying discrepancies, and supporting documentation completion and closure. - Investigation and documentation skills: Strong analytical abilities and a methodical approach to investigating quality issues, documenting findings, and maintaining accurate records. - Quality and compliance knowledge: Familiarity with regulated quality systems, documentation standards, and procedures applicable to pharmaceutical or life sciences operations. - Organizational skills: Ability to manage multiple assigned records, prioritize activities, meet deadlines, and deliver results within a defined six-week project period. - Communication and escalation: Strong written and verbal communication skills, with the ability to explain findings, identify exceptions, and raise concerns clearly and promptly. - Independent working style: Comfortable taking ownership of responsibilities, managing milestones, and delivering results with limited day-to-day supervision. - On-site availability: Willingness and ability to work on-site at the client facility in Chicago, Illinois, for the duration of the project. Benefits - Project-based opportunity: A focused six-week engagement offering the opportunity to contribute to important quality and compliance activities.