Quality Systems Technician

Description

Main Areas of Responsibilities
Maintaining system stability (e.g., repairs and maintenance), 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.
The position will review 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.
Incumbent will identify 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. Performs other duties as assigned
Requirements
Three (3) years experience in pharmaceutical manufacturing chemistry lab or transferrable experience in a manufacturing role.
Functional user knowledge of Microsoft Office. Experience with LIMS and Trackwise preferred, with the ability to learn other computer based systems.
Understanding of CFRs, QSIT, ISO standards.
Experience working in an aseptic environment preferred.
Preferred Skills/Qualification
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. Must have knowledge of laboratory automation and data management technologies to support Allergans 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.
Capability to understand and make use of technical writing.
Demonstrated mechanical aptitude.