Senior Clinical Quality Assurance Associate

Location: Carlsbad, California US

Notice

This position is no longer open.

Job Id: 512

Position Title: Senior Associate, Clinical Quality Assurance

External Description:

At Agility Clinical, we are a team of clinical trial experts who are dedicated to the success of our clients, so that ultimately patients can receive much-needed treatments. We believe the success of a company is much more about what it does every single day and how it does it, than about its revenues. From the beginning, we have fostered a culture where patients’ needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community. We are very proud of the team at Agility and what it has achieved thus far.

We're looking for a Senior Clinical Quality Assurance Associate with clinical research and vendor audit experience to provide support in the implementation of our quality management system. Are you ready to be an integral part of a dynamic and growing clinical research organization in a company with diverse product offerings such as pharmaceutical, diagnostics and medical device?

About You:

  • You love travelling for business
  • You enjoy conducting a variety of vendor audits in both pharma and device trials
  • You love being in a consultative role where you can provide your GCP/ICH expertise to the team
  • You commonly focus on intricate details of a situation yet you are able to see the overall big picture
  • You enjoy establishing new groundwork in QA with risk based management strategies
  • You love being a mentor and a collaborator, sharing your knowledge to help grow and encourage peers and team members

Here are some of the high level aspects of the role:

  • Administer Quality Management System, including SOP, training, and CAPA systems
  • Host client/sponsor audits and regulatory inspections
  • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits
  • Orchestrate and lead internal audits of quality systems, investigator site audits, trial master file audits and documentation audits
  • Develop and administer training for employees and consultants
  • Participate in computer systems validation projects and systems change control process
  • Provide QA consultation and support to assigned project teams internally and externally and according to defined quality oversight plans as applicable
  • Monitor quality systems to provide feedback on compliance risks to QA management and find opportunities for improvement

Qualifications:

Minimum Required:

  • Bachelor’s degree in a science, healthcare, or related field of study
  • Two to five years of applicable experience or equivalent combination of education and experience

Other Required:

  • Clinical research experience in non-QA role considered (e.g. clinical research associate experience)
  • Pharmaceutical and/or Medical device experience
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
  • Travel requirement of up to 25-50%; domestic and international
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
  • Customer service demeanor, including proven collaboration and flexibility, teamwork, and a keen attention to detail
  • Excellent written and verbal interpersonal skills
  • Proven ability to work successfully both independently and in a team environment
  • Successful history working with cross functional groups and management under challenging situations
  • Shown ability to prioritize work and handle multiple and/or contending assignments

Preferred:

  • QA certification (e.g. CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g. EDC, CTMS, IxRS, ePRO, etc.)

Division: Precision For Medicine

Business Unit: Oncology & Rare Disease

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available: No

City: Carlsbad

State: California

Community / Marketing Title: Senior Clinical Quality Assurance Associate

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC

Location_formattedLocationLong: Carlsbad, California US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

Privacy Policy

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

© 2018 Precision Medicine Group, Inc. All rights reserved