Quality Record Investigation Lead Consultant

ProPharma; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

ProPharma is seeking a consultant to review, investigate, document, and close low-risk non-conformance and batch-related records within a six-week timeframe at the client site in Chicago, IL. The role requires strong investigation, documentation, and batch record review experience and the ability to work independently in a client environment.

You will interface with the client, manage milestones, provide weekly status updates, escalate risks, and oversee team productivity while supporting

Qualifications

• Strong investigation, documentation and batch record review experience.
• On-site at Chicago, IL for six-week project.
• Ability to manage milestones, deliverables and client communications.

Responsibilities

• Primary client interface
• Project management and KPI tracking
• Weekly status reporting
• Risk and issue escalation
• Team oversight and productivity management
• Support execution of exception and non-conformance investigations and closures as needed

Skills

Project management

Investigation

Documentation

Batch records

Risk management

Client liaison

Education

Bachelor's degree in life sciences or related

Tools

TrackWise

Microsoft Excel

Job description

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. Consultant should have strong investigation, documentation, and batch record review/closure experience and be comfortable working independently within the client environment. This consultant will assume responsibility for overall execution, milestone management, and delivery performance. Primary duties will include:

• Primary client interface
• Project management and KPI tracking
• Weekly status reporting
• Risk and issue escalation
• Team oversight and productivity management
• Support execution of exception and non-conformance investigations and closures as needed

#LI-JH1 #LI-ONSITE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you’re successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.