Quality Record Investigation Consultant

PPG US ProPharma Group, LLC; Raleigh (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

ProPharma is seeking a consultant to review, investigate, document, and close low-risk non-conformance and batch-related records at our client site in Chicago, IL for a six-week engagement.

The role requires strong investigative and documentation skills, proficiency in batch record review and closure, and the ability to work independently within a client environment.

All work is performed on-site; candidates should be prepared to manage milestones and deliver within the project timeline.

Qualifications

• Experience in investigation, documentation, and batch record review/closure.

Responsibilities

• Review assigned records
• Perform investigations and documentation activities
• Complete Record closure activities
• Escalate issues, exceptions, and support needs appropriately #LI-JH1 #LI-ONSITE

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:

• Review assigned records
• Perform investigations and documentation activities
• Complete Record closure activities
• Escalate issues, exceptions, and support needs appropriately #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.