Allergan Data Integrity Engineer, QA Laboratories in Waco, Texas
Data Integrity Engineer, QA Laboratories
Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/6148/other-jobs-matching/location-only
Jul 31, 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.
This position will be responsible for: overseeing the data integrity of analytical laboratories and performs routine audits of both metadata and reports. Revises procedures and improves processes to ensure laboratories are compliant with current regulatory expectations related to data integrity. Co-investigates out-of-limit conditions and coordinates with Laboratory Management to implement corrective action(s). Prepares trend and metric laboratory reports in conjunction with laboratory managers. Reviews current regulatory and technical journals to provide guidance and support manufacturing regarding chemical and microbiological data integrity issues. Assumes additional tasks as required.
Main Areas of Responsibilities
Oversees the data integrity of analytical laboratories and performs routine audits of both metadata and reports to ensure data integrity compliance.
Responsible for general laboratory cleanliness and housekeeping.
Responsible for maintaining a safe working environment.
Assists in continual improvement of lab using OPEX concepts.
Revises procedures and improves processes to ensure laboratories are compliant with current regulatory expectations related to data integrity.
Co-investigates out-of-limit conditions and coordinates with Laboratory Management to implement corrective action(s).
Prepares trend and metric laboratory reports in conjunction with laboratory managers.
Reviews current regulatory and technical journals to provide guidance and support manufacturing regarding chemical and microbiological data integrity issues.
Excellent analytical skills and problem-solving skills.
Strong learning agility for new tasks and non-standard analysis.
Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
Ability to perform detailed tasks and document activities accurately.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Ability to read, comprehend, write, and communicate effectively in English.
Excellent knowledge and understanding of electronic lab data acquisition and analysis software, Empower and LabX data collection and analysis software preferred.
Excellent knowledge and understanding of quality and business management software systems and processes. Preferred experience with Trackwise and SAP.
Excellent knowledge and understanding of Validation of laboratory software and analytical testing. Experience with investigations for electronic and analytical testing deviations.
Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer based systems.
Strong written and verbal communication skills.
Ability to work with minimal supervision.
Ability to provide direction for functional area.
Physically able to continuously stand and walk.
Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
Minimum (7) years of experience with electronic data capture and analysis software for chemistry analysis.
Expertise with data integrity guidance documents including FDA, MHRA, WHO, PIC/S.
- B.S. degree in Science, with a minimum of ten (10) years of lab experience. Chemistry or Microbiology preferred.
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.