Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Responsible for the administration of Quality Control Department computer systems, repairs and maintenance of the Laboratory Instruments and Computer Systems of Quality Laboratories. Maintains system stability, data integrity, and develops and executes procedures to maintain these systems and equipment in a validated and secure manner in accordance with FDA Code of Federal Regulations and other applicable regulatory requirements.

This position is also responsible for the following:

* Maintaining system stability, monitoring of data integrity, and development and execution of procedures to maintain these systems in a validated and secure state in accordance with FDA Code of Federal Regulations and other applicable regulatory requirements.

* Responsible for the assistance of the Chemistry Laboratory staff for the execution of validations protocols covering laboratory operations.

* Provides oversight of Quality computer systems through administration of the software and, where applicable, the associated equipment.

* Reviews the audit trails and message centers of the respective software systems to ensure that they are maintained in a secure state and provide assistance to resolve identified concerns.

* Identifies opportunities, lead efforts, and coordinate project teams for continuous improvement of laboratory instruments and software systems.

* Position provides technical oversight for troubleshooting of the laboratory instruments and software systems and works with Information Systems, the manufacturer, and corporate facilities to resolve issues in a timely and efficient manner.

* Writes, reviews, and, as necessary, approves the documentation required by the various regulatory firms to ensure that the systems are tested and operate in a manner consistent with a controlled and validated system.

* Performs other duties as assigned.

Qualifications
Education

* Bachelors Degree in Chemistry or related Sciences.
* Ten (10) years of experience as Chemist or Instrument Specialist or technical role relative to Quality Control in pharmaceutical or medical devices preferred.
* Five (5) years of laboratory experience in regulated environment preferred. Three (3) years of experience in analytical equipment validation preferred.
* LIMS (preferred). MS Office (Word, Excel, PowerPoint), Empower, MODA, Lab-X (preferred).
* Understanding of CFRs, QSIT, ISO standards.
* Experience working in a GMP regulated environment.

Essential Knowledge, Skills & Abilities

* Basic Quality System knowledge (any or all of FDA/GMP, ISO 13485:2003, Mil STD, QSIT).
* Strong computer skills (Excel, PowerPoint, SAP, Empower, LIMS, etc.).
* Excellent analytical skills and effective problem-solving skills.
* Capability to understand and make use of technical writing.
* Must have knowledge of laboratory automation and data management technologies to support global operations. This includes Lab Information Management System (LIMS), Chromatography Data Systems and other instrument control and data management systems. Competent setting up, operating, and troubleshooting all laboratory instrumentation.
* Skill to communicate effectively with all levels of the organization.
* Ability to thrive in a team environment.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.