GCLP Auditor (Freelance - CAP/CLIA experience required)

Ergomed Group; Raleigh, Northern (NC, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group is seeking a GCLP Auditor with CAP/CLIA experience. The role supports GCP Compliance and involves planning, conducting, and reporting GCLP audits for pharmaceutical/biotechnology clients. Remote audits and up to 40% travel are expected.

The ideal candidate has a Life Science background, leads internal and external audits, and can coordinate inspection readiness for sponsor and site inspections. This is a full-time role based in Raleigh, NC.

Qualifications

• GCLP audits leadership and execution
• Experience with CAP/CLIA audits
• Strong regulatory and quality systems understanding

Responsibilities

• Plan, prepare, conduct, report and follow up GCLP audits (CAP/CLIA)
• Coordinate and manage inspection preparation activities
• Perform GCLP QA projects for clients in pharma/biotech
• Conduct remote audits as needed

Skills

GCLP audits

Audit leadership

Regulatory knowledge

Education

BSc Life Science

Job description

GCLP Auditor (Freelance - CAP/CLIA experience required)

• Full-time
• Department: GCP Compliance

Medicine moves forward here. So will you.

ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GCLP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences.

We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.

Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.

Planning, preparation, conduct, reporting and follow up of various types of GCLP audits including CAP/CLIA according to expected quality and timelines

Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical LaboratoryPractice (GCLP).

Performing GCLP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

BSc in Life Science preferred

Experience in conducting and leading internal and external GCLP audits including CAP/CLIA for a variety of stakeholders

Experience in conducting a range of service provider audits

Experience in conducting GCLP systems audits.

Experience in coordinating and managing inspection preparation activities for GCLP process inspections both at the sponsor and investigator site.

Experience in conducting GCLP mock inspections to Competent Authority standard considered a significant advantage.

Expert knowledge of national and international GCLP legislation and guidelines

Up to 40% travel and ability to conduct remote audits

Why ADAMAS?

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.