Quality Record Investigation Consultant

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. Professional experience: Gain further hands-on experience in quality investigations, batch record management, and regulated life sciences operations. Ownership and autonomy: Take responsibility for project execution, milestone management, and the timely delivery of quality records. Collaborative environment: Work directly within a client organization and coordinate with relevant stakeholders to resolve issues and complete assigned activities. Compensation: Salary or contract rate details have not been specified in the available job description. Additional benefits: Healthcare coverage, paid time off, bonuses, and other benefits have not been specified for this project-based opportunity.