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QA Coordinator

Covance 6/6/2018 5:10:34 AM
JOB ID: 20681 Category: Quality Assurance
Research Triangle Park, North Carolina

   

 

Job Overview

Assures the administrative needs are met by supporting functions such as scheduling audits, global SOP/P&P maintenance, and supply management. Coordinates and administers the Global SOP and P&P systems including typing, developing/writing, record keeping, and distribution of materials to all global Covance Clinical Pharmacology sites. Responsible for preparing, maintaining and communicating auditing schedules for facility, investigator site, in-process, Study Master File, data and report audits across multiple sites and disciplines. Communicates to all auditors and study direction staff all changes in the schedule. Prioritizes work by consulting with QA management as needed. Manages the reporting of metrics for the QA department at all sites.

1. Duties and Responsibilities:

* Evaluates and responds to scheduling requests
* Maintains the schedule in a current state at all times
* Prepares and distributes schedules to all auditors
* Works with QA management to maintain an equitable distribution of the workload and assign work to cross trained auditors
* Works with QA management to identify and take appropriate action with problems, or potential problems with scheduling conflicts.
* Must be computer literate, uses advanced word-processing functions (tables, macros, and charts) and willing to upgrade skills as needed to remain current in the field.
* Prepares metrics as requested by QA management
* Acts as the Global Covance Clinical Pharmacology SOP and P&P administrator which includes developing, tracking, typing, copying, distributing, filing, and maintaining historical files of all company SOPs and P&Ps
* Issues and tracks SOP and P&P biennial and 6-year review notifications
* Performs a quality control check (or delegates this check) on all SOPs and P&Ps before distributing
* Loads SOPs and P&Ps into eDOCS on their effective date.
* Provides support to the QA unit in all aspects of administrative duties, including managing supply order.
* May proof read and examine documents and letters for completeness, adherence to company policies and procedures, accuracy of composition, form, and presentation.
* Assists with multi-site initiatives and harmonization of administrative functions
* Completes self-development opportunities.
* Performs other related duties as assigned.

Education/Qualifications

* Bachelor of Science/Arts (BS/BA) degree in science or related field
* Experience with work performed and audits required by QA
* Familiarity with regulatory guidelines. Previous Experience in a FDA regulated field or Clinical Research is preferred.
* Ability to effectively interact with internal and external clients
* Ability to effectively negotiate ideas and suggestions.
* Proven organization, observation, and problem solving skills.
* Skilled in concise writing
* Ability to perform intermediate/advanced computer skills (e.g., Word, Excel, PowerPoint, Visio, Microsoft Project, Minitab)

Experience

* Two years of Experience with BS/BA degree
* Experience may be substituted for education. For example, an Associates Degree plus five years applicable Experience may be substituted for an Bachelors of Science/Arts degree


Position Type: Full-Time

Location: Research Triangle Park, NC - North Carolina



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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).