Quality Record Investigation Consultant
About the role
For 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.
Responsibilities
- Review assigned records
- Perform investigations and documentation activities
- Complete Record closure activities
- Escalate issues, exceptions, and support needs appropriately
- Assume responsibility for overall execution, milestone management, and delivery performance
Requirements
Strong investigation, documentation, and batch record review/closure experience; comfortable working independently within the client environment.
Schedule
Six‑week on‑site project located in Chicago, IL.