Quality Record Investigation Consultant

<h3>Accountabilities</h3><li>
<strong>Review quality records:</strong>Examine assigned records to verify accuracy, completeness, and consistency with applicable quality procedures and documentation standards.</li><li>
<strong>Conduct investigations:</strong>Investigate low-risk non-conformances and batch-related issues, gathering relevant information and documenting findings clearly and accurately.</li><li>
<strong>Manage documentation:</strong>Prepare and maintain thorough investigation records, ensuring that all required information is properly captured and traceable.</li><li>
<strong>Drive record closure:</strong>Complete assigned record closure activities within the established project timeline, ensuring that documentation requirements are met.</li><li>
<strong>Manage project delivery:</strong>Take ownership of assigned activities, monitor milestones, and ensure timely and effective execution of responsibilities.</li><li>
<strong>Escalate issues appropriately:</strong>Identify exceptions, unresolved discrepancies, and support needs, communicating them promptly to the relevant stakeholders.</li><li>
<strong>Work independently:</strong>Operate effectively within the client’s on-site environment while maintaining productivity, quality standards, and accountability for deliverables.</li><h2>Requirements</h2><li>
<strong>Relevant experience:</strong>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.</li><li>
<strong>Batch record expertise:</strong>Proven hands-on experience reviewing batch records, identifying discrepancies, and supporting documentation completion and closure.</li><li>
<strong>Investigation and documentation skills:</strong>Strong analytical abilities and a methodical approach to investigating quality issues, documenting findings, and maintaining accurate records.</li><li>
<strong>Quality and compliance knowledge:</strong>Familiarity with regulated quality systems, documentation standards, and procedures applicable to pharmaceutical or life sciences operations.</li><li>
<strong>Organizational skills:</strong>Ability to manage multiple assigned records, prioritize activities, meet deadlines, and deliver results within a defined six-week project period.</li><li>
<strong>Communication and escalation:</strong>Strong written and verbal communication skills, with the ability to explain findings, identify exceptions, and raise concerns clearly and promptly.</li><li>
<strong>Independent working style:</strong>Comfortable taking ownership of responsibilities, managing milestones, and delivering results with limited day-to-day supervision.</li><li>
<strong>On-site availability:</strong>Willingness and ability to work on-site at the client facility in Chicago, Illinois, for the duration of the project.</li><h2>Benefits</h2><li>
<strong>Project-based opportunity:</strong>A focused six-week engagement offering the opportunity to contribute to important quality and compliance activities.</li><li>
<strong>Professional experience:</strong>Gain further hands-on experience in quality investigations, batch record management, and regulated life sciences operations.</li><li>
<strong>Ownership and autonomy:</strong>Take responsibility for project execution, milestone management, and the timely delivery of quality records.</li><li>
<strong>Collaborative environment:</strong>Work directly within a client organization and coordinate with relevant stakeholders to resolve issues and complete assigned activities.</li><li>
<strong>Compensation:</strong>Salary or contract rate details have not been specified in the available job description.</li><li>
<strong>Additional benefits:</strong>Healthcare coverage, paid time off, bonuses, and other benefits have not been specified for this project-based opportunity.</li>