Kelly Services Quality Assurance Auditor - Scientific in Boulder, Colorado

GMP Quality Systems and Compliance Contractor ( 40-45 per hour)

6 month temporary assignment - Manager Level

Boulder, CO

Summary:

This position is responsible for hands-on execution of various tasks in the Quality Systems and Compliance Group. The successful candidate is self-driven, works with minimal direction, has well-rounded experience in previous Quality and/or Compliance roles, a working knowledge of Quality Systems and Compliance, e-Compliance, Regulatory Authority Inspections/Reporting and Market Action in a GMP environment.

Responsibilities:

Provide hands-on execution of Quality System and Compliance activities including:

  • Scheduling and coordinating GMP external audits and developing appropriate corrective and preventive action plans as appropriate working closely with Quality Operations.

  • Assisting in the scheduling and execution of GMP internal audits if needed.

  • Establishing and maintaining templates for inter-company Quality Agreements.

  • Developing and maintaining new program to assure compliance with the Prescription Drug Marketing Act (PDMA).

  • Assisting with tasks in the MasterControl documentation system if needed.

  • Assisting in developing and managing the Quality Regulatory Intelligence Program.

Requirements:

  • BS/BA Degree in a scientific field.

  • 10 years of experience in a GxP Quality or Compliance position in the biotech or pharmaceutical industry.

  • Ability to perform quality and compliance related tasks independently with minimal oversight.

  • Demonstrated ability to accomplish results and meet deadlines and commitments.

  • Strong organizational skills, ability to multitask in a dynamic, fast paced environment.

  • Strong collaboration and written/verbal communications skills.

  • Strong interpersonal and “people” skills and the ability to positively interact with many levels of individuals across various departments and companies.

  • Looking for local candidate with ability to work fulltime onsite at the Boulder facility.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.