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
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.
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.
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.