Job Directory Quality Enterprise System Administrator

Quality Enterprise System Administrator
Plainsboro, NJ

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About

Job Description

Overview

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

As part of Integra's IS Compliance Function the Quality Enterprise Systems Administrator will be responsible for administering, configuring, and supporting the eTQ Reliance® application for various business units as well as other Enterprise Quality applications. Implementation process includes analyzing business requirements, installing eTQ Reliance® software, system configuration and completion of key validation documentation and activities. In addition, provide support for system issues that arise and make sure any updates and patches are rolled out in conformance with computers systems validation processes. The candidate must be hands on successful in handling multiple projects simultaneously and delivering results within defined timelines.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

* Develop and configure new and existing processes including analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions, login accounts, record types and settings.
* Review scheduled system releases/upgrades and determine impact on Quality processes, system configurations, customizations and recommend possible implementation scenarios to the business.
* Partner with the vendor to support the eTQ Reliance® and Veeva systems and manage the release schedule with the vendor and the business.
* Create validation deliverables such as URS, FRS and Configuration Specification documentation, including flow charts and customized reports following Integra's CSV and Change control process to maintain the system in a validated state.
* Implement eTQ Reliance® and other Quality systems.in conjunction with 21 CFR Part 11 (Electronic Records and Electronic Signatures), Current Good Manufacturing Practices (cGMP), and related FDA regulations.
* Develop a strong partnership with IS and quality users to achieve business and project goals.
* Travel to Integra facilities or locations for extended periods based on the projects and business needs.

Strong written and verbal communication skills and the ability

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

* BA/BS degree in Computer Science or Software Engineering.
* Knowledge of supporting SAAS applications for regulated businesses.
* 5+ years of relevant experience in pharmaceutical/medical device industry.
* Involved in multiple full project implementations from project planning to go live.
* Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practices.
* Knowledge of GxP, GAMP5, 21CFR Part11 and industry best practices.
* 2-3 years of proven experience in an analytical or business/quality systems environment.
* Familiarity with any database management system (DBMS) such as Oracle and/or MS SQL Server
* Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
* Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
* Ability to work independently with minimal supervision.

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