About this role
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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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