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Senior Quality Assurance Auditor (GCP)

Covance 9/28/2018 12:23:23 PM
JOB ID: 21470 Category: Quality Assurance
Houston, Texas

   

 

Job Overview

Supports Senior Management in maintaining robust quality systems and assure regulatory compliance within Clinical Pharmacology (CPS). Proactively drives improvement in the Quality Assurance (QA) organization as well as in the Operations practices. Provides interpretation of external requirements and develops practical solutions to attain full compliance. Interacts independently with staff members of other functional groups and senior management to resolve issues.

Represents the company in preparation for and hosting of regulatory inspections and client audits, as needed. Represents the company in direct interactions with client auditors and Health Authority investigators. Audits studies, protocols, data and reports in compliance with appropriate SOPs, and GCP requirements,. Initiates and facilitates quality improvement objectives throughout the organization. Performs external audits of service providers. Mentors less Experience d staff.

Duties and Responsibilities:

* Hosts client audits and interacts with Health Authority inspectors to represent the company.
* Coordinates preparations for, and participates in regulatory inspections.
* Act as an expert on broad based routine (day-to-day) regulatory compliance issues, and provide leadership to teams in areas of regulatory compliance.
* Interprets GCPs and associated regulatory documents to facilitate auditing and process improvement recommendations.
* Audits protocols, phases of clinical studies, reports, and performs related duties (e.g. schedules studied/inspections, issues QA statements) to ensure regulatory compliance.
* Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Data Services, IRB, Archives, Vendor and Facility Audits).
* Writes and issues audit reports. Works with internal customers to ensure that inspection findings are clearly communicated and understood. Evaluates inspection-finding responses to ensure they are written to address the findings appropriately.
* Identifies and communicates, with little or no supervision, opportunities for process improvement. Participates in and guides process improvement activities in both small intradepartmental group as well as complex and possible multi-departmental interactions.
* Is able to present in small group training on specific GCP topics.
* Mentors less Experience d auditors.
* Notifies management of observed quality and compliance trends.
* Schedules and coordinates work with study project teams and supervisor/peers in Quality Assurance.
* Special Projects
* Lead/participate in QA projects
* Supports special projects requiring QA input

* QA Global Lead /Representation
* Represent QA on Project teams, management meetings, and other internal forums
* Represent QA at client meetings and/or their third party auditors
* Represent QA with specific clients as assigned
* Interact independently with client representative(s) as applicable
* Track & ensure resolution to client issues as applicable
* Inform management of client concerns as applicable.
* Meet all timelines established with client representative(s) to assure superior client service
* Direct and regular communication with the Covance lead contact(s) for preferred partner relationships

* Performs other related duties as assigned.

Education/Qualifications

Required:

* Batchelor of Science/Arts (BS/BA) degree, preferred in a science related field.
* Recognized expertise in quality assurance practices and mastery of GCP regulatory compliance requirements. Excellent technical knowledge, understanding and Experience in applying ICH/FDA Good Clinical Practices.
* Proficient in use of computer and Microsoft software programs (e.g., Word and Excel).
* Ability to effectively interact with CRU pharmacometrics, management and scientific staff. Ability to independently negotiate, provide constructive feedback and support process improvement initiatives.
* Skilled in both verbal and written communication to effectively communicate and negotiate.

Experience

Required:

* Minimum of 8 (eight) years Experience in the pharmaceutical/CRO industries, with at least 4 (four) years in Clinical Quality Assurance, preferably within a GCP environment.
* Additional Experience may be substituted for education requirements.


Position Type: Full-Time

Location: Houston, TX - Texas



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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).