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Quality Assurance Manager

Kelly Scientific Resources Boulder Full-Time
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REMOTE Quality Assurance GCP/GLP Manager - long term contract, possible contract to hire Can work remotely   Job Description: The Quality Assurance GCP Manager is responsible for arranging, conducting and reporting on GCP audits of clinical research organizations, vendors, and systems as well as oversight of the Clinical Operations and Clinical Trials. Participates in cross-functional teams providing guidance and risk-based options. Reviews study documents and checks for consistency and appropriate standards and practices. Assists in the creation and maintenance of audit tools. When appropriate, prepares and/or revises GCP SOPs and Work Instructions. Works with cross-functional teams to provide GCP advice. Maintains good working relationships and communication with GCP customers and staff.   Essential duties include: • Performs Quality Control (QC) of clinical and non-clinical data as well as clinical documents (protocol, IB, etc.). • Ensures Clinical Operations and Clinical Trials are complaint with FDA and ROW regulatory expectations; • Arranges, conducts and reports on GCP audits of clinical research organizations, investigators, vendors, and systems • Develops and maintain quality procedures aligned with GCP concepts • Works within cross-functional teams, ensuring compliance to regulatory guidance and internal document standards; • Works directly with CRO’s and other external contractors and collaborators, managing the chain of communication related to GCP compliance; • Approximately 5-10% travel per year - US travel   Qualifications: Suitable candidates will possess a Bachelor’s degree in a Life Science or Engineering, and 8+ years of Quality Assurance experience in the Biotechnology and/or Pharmaceutical industry. Extensive knowledge of clinical trials in the US and EU and regulatory standards at all phases of drug development is preferred.   Required Skills: • Clear record of success as a QA Manager in a biopharma or pharmaceutical environment; • Clear understanding of FDA and international regulatory requirements; • Adept at prioritizing and completing tasks in a high-pressure environment; • Proven leadership within a cross-functional project team; • Ability to persuasively and effectively interact with partners, collaborators and CRO’s; • Demonstrated ability to anticipate and address issues; • Exceptional oral and written communication skills including excellent technical writing abilities.





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.



About Kelly 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 URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

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. URL blocked - click to apply

 

Recommended skills

Product Quality Assurance
Clinical Research
Good Clinical Practices (Gcp)
Clinical Trials
Biotechnology
Safety Assurance
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In a recent study, one-third of large companies predicted contingent workforce growth of 50 percent or more.* Kelly Scientific Resources® can help you be a part of this contingent workforce growth opportunity.

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines, including:

  • Biomedical
  • Biotechnology
  • Chemical
  • Clinical Trials / Clinical
  • Clinical Research
  • Consumer Products
  • Cosmetics
  • Drug Discovery and Safety
  • Environmental Health
  • Food Science
  • Health Physics
  • Laboratory
  • Pharmaceutical
  • Production and Manufacturing
  • Quality Assurance and Control
  • Research and Development

Kelly Scientific Resources employees work more than 7 million hours in positions ranging from clinical research associates to molecular biologists to biochemists—from entry level to Ph.D.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year.

Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices.

Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

*According to “The Emerging New Workforce,” a 2009 report by Littler Mendelson, P.C., an employment and Labor Law solution firm.

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