IT'S NOT JUST
A JOB.

To us it’s personal.

Senior Quality Assurance Auditor

Covance 10/18/2018 6:16:26 PM
JOB ID: 24413 Category: Quality Assurance
King of Prussia, Pennsylvania

   

 

Job Overview

The Senior Quality Assurance Auditor can be remotely located anywhere in the United States.

Essential Job Duties:

* Lead audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
* Leads complex audits (e.g., directed, process, systems, office)
* Provide suitable recommendations for audit observations; ensures auditors deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
* Proactively identifies and leads process improvement activities / SOP creation and revisions
* Able to host client audits and able to support regulatory inspections
* Leads and/or participates in special projects
* Represents Audit QA on project teams and other internal forums
* Trains and mentors junior QA Audit staff/ support on-boarding of new personnel

Education/Qualifications

Required:

* University/college degree BA/BS (life science preferred),or equivalent
* Thorough 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

Competencies:

Required:

* 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

Desired:

* Core and Leadership Competencies: Focus on clients, Works well with others, Develops self and team, and Gets it done

Working Conditions:

* Remotely (home-based), traveling to other Covance offices, sponsor premises, investigator sites, pharmacies, third party vendors when required

Experience

Experience : Minimum Required:

* 5 years CRO/Pharmaceutical Experience
* 4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required


Position Type: Full-Time

Location: King of Prussia, PA - Pennsylvania



APPLY TO THIS JOB DOWNLOAD PDF

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).