Raleigh, North Carolina

Kelly is actively recruiting for Direct Hire GCP Auditor position within the Pharmaceutical Industry.  

To provide professional, high caliber quality assurance and quality management services to the pharmaceutical industry.  Duties will be carried out in accordance within the Quality Management System (QMS).

General Responsibilities

  • Perform projects which fall within the job holder’s areas of expertise (GLP and GcLP) on behalf of client companies within the pharmaceutical industry
  • Actively participate in the Clients Learning and Development System
  • Perform other reasonable duties as requested by the job holder’s Line Manager

Projects

This may include audits, preparation of training material and delivery of training, development of QMS/Standard Operating Procedures (SOP) and general consultancy.  Specific duties may include:

  • Delivery of projects in compliance with agreed project proposals and budgetary constraints
  • Performing the role of Project Lead, Lead Auditor, Client Contact, Co-auditor or Consultant
  • Project management, including project plan preparation, project oversight, and archiving/destruction of project documents
  • Audit management, preparation, conduct, reporting, follow up and archiving/destruction of audit documents
  • Delivery of consultancy services (e.g. SOP development, quality system advice, general advice on regulatory compliance issues)
  • Preparation of training material and training delivery

Learning and Development

Consultants must maintain an up to date knowledge of domestic and international regulatory requirements and industry guidelines/best practices governing the pharmaceutical industry as relates to GLP/ GcLP and Bioanalytical Guidance Documents. Advantage should be taken of learning and development opportunities to facilitate increasing competence and achieving the job holder’s full potential.  This will include:

  • Participation in the process whereby knowledge and learning are shared across the organization (i.e., by attending training meetings and presenting when requested)
  • Maintaining competence records to provide evidence that individuals have the necessary education, training, experience, and skills to perform their assigned tasks
  • Attendance at external training courses
  • Participation in ‘on-the job’ training, this may be either as a trainee or trainer
  • Reading publications and other sources of literature, e.g. regulatory authority websites, CQA Advisor, QUASAR

Other Duties

The job holder may be requested to assist with other aspects of the clients activities, including (but not limited to):

  • Projects defined in SMART objectives
  • Non-critical QC of project deliverables
  • Assistance with the Client QMS e.g. QMS document preparation and review, process improvement initiatives, internal and client audits, supplier audit programs


Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Raleigh, North Carolina

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

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