Quality Record Investigation Consultant

ProPharma

Raleigh, United StatesOn-siteFull time
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Location
Raleigh, United States
Work style
On-site
Job type
Full time
Posted
Oct 12
8 days ago
Career path

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About the company

ProPharma

Management consulting · 5,001 to 10,000 employees

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.

ProPharma on LinkedIn

What you'll do

  • Review assigned records and perform investigations, documentation, and record closure activities.
  • Escalate issues, exceptions, and support needs.

What you need

  • Strong investigation, documentation, and batch record review/closure experience; comfortable working independently within the client environment.

Key skills

investigationdocumentationbatch record reviewrecord closure

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Read the full posting here
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. Job Description 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. 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. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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