Allergan Quality Systems Technician IV in Waco, Texas
Quality Systems Technician IV
Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/5163/other-jobs-matching/location-only
Apr 24, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Responsible for the administration of Quality Control Department computer systems. Also responsible for the repairs and maintenance of the Laboratory Instruments and Computer Systems of the Quality Control Quality Systems Technician IV Laboratories. Responsible for maintaining system stability, data integrity, and development and execution of procedures to maintain these systems and equipment in a validated and secure state in accordance with FDA Code of Federal Regulations and other applicable regulatory requirements.
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
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 CFR’s, QSIT, ISO standards.
Experience working in an aseptic environment preferred.
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 Allergan’s 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.
- Bachelor’s Degree in Chemistry or related sciences. Minimum one (1) year experience in pharmaceutical manufacturing (e.g., Compounding, Maintenance).
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.