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Quality Assurance Associate

Quality Assurance and Compliance – Aurora, Colorado
Department Quality Assurance and Compliance
Employment Type Full-Time
Minimum Experience Mid-level

We are looking for a Quality Assurance Associate to join our team!

Are you someone who is organized and has a knack for details? Someone with background in clinical research quality management? Someone who is able to see the bigger picture and adapts to change easily? If the answers are yes, keep reading!

In this position you will have the following responsibilities:

Primary Responsibilities

  • Identify process gaps and assist with revising policies (POLs), standard operating procedures (SOPs) and work instructions (WIs) to ensure compliance with applicable regulations and guidance.
  • Provide input on quality issues to the Director of Quality and Compliance.
  • Review regulatory and other assigned clinical trial documents for GCP compliance and report findings to applicable functional area(s) and Director of Quality and Compliance.
  • Serve as an internal resource to address and resolve any questions or issues of a regulatory or quality assurance nature with the assistance of the Director of Quality and Compliance. 

Secondary Responsibilities

  • Assist in the implementation and administration of CPC’s regulatory and Quality Management Systems, programs and activities, as assigned.
  • Support internal auditing functions to ensure that CPC is compliant with all applicable local, federal and international regulations, guidelines and standards.
  • Assist with external audits of CPC.
  • Understand and comply with all applicable regulations for clinical trials and relevant CPC POL, SOPs and WIs.

Here’s what you will need to bring to the table:

  • Bachelor’s degree preferred, but equivalent experience will be considered.
  • Minimum of 4 years of experience in a clinical research setting (required) including Quality Assurance responsibilities. Previous CRO experience is preferred.
  • Knowledge of applicable regulatory requirements (e.g. ICH, GCP and FDA) for conducting clinical trials.
  • Proficiency with Microsoft Office and Adobe.
  • Ability to work independently as well as on a team.
  • Good problem-solving skills and ability to prioritize.
  • Attention to detail and exceptional organizational skills.
  • Ability to manage tasks independently and to prioritize multiple tasks.

Note: Viable applicants will be required to pass a background and education verification check.

About CPC:

CPC is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 25 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan
• 10 paid holidays
• In-suite exercise room
• In-suite relaxation room
• In-office masseuse 3x/month
• Monthly fun events (i.e. sports games, potlucks, picnics)
• Flexible work schedules

Visit our web site to learn more about us and values we embrace: www.cpcmed.org.

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age 40 and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please e-mail our Human Resources team at careers@cpcmed.org

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  • Location
    Aurora, Colorado
  • Department
    Quality Assurance and Compliance
  • Employment Type
  • Minimum Experience
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