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Sr Auditor QA&C

Covance 6/6/2018 5:10:32 AM
JOB ID: 20680 Category: Quality Assurance
Regional, Nationwide

   

 

Job Overview

Sr. QA Auditor (GCP Auditor)

(home or office based position)

Leads audit teams in the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards

* Conducts complex, directed, and/or time sensitive QA audits
* Participates in global QA audits
* Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
* Leads process improvement activities / SOP updates
* Able to support client audits and regulatory inspections
* Leads and/or participates in special projects
* Represents Audit QA on project teams and other internal forums
* Trains and mentors junior staff
* Excellent written and oral presentation skills
* Excellent organization and planning skills and attention to detail
* Proven interpersonal skills
* Demonstrated ability to handle multiple competing priorities across clinical operating unit
* Ability to function as a member of a global clinical team
* Core and Leadership Competencies: Focus on clients, Works well with others, Develops self and team, and Gets it done

Education/Qualifications

* University/college degree BA/BS (life science preferred)
* Knowledge, understanding, and Experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
* Knowledge of the drug development process from the perspective of a contract research organization
* Spanish fluency perferred but not required

Experience

* 4 years CRO/Pharmaceutical Experience
* 3 years in a GXP quality role, including at least 1 year in a GCP quality role required


Position Type: Full-Time

Location: Regional, NAT - Nationwide



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).