Allergan Quality Engineer I in Cincinnati, Ohio
Quality Engineer I
Cincinnati, Ohio, United States at https://agn.referrals.selectminds.com/jobs/5406/other-jobs-matching/location-only
May 17, 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.
The Quality Engineer I will be responsible for the execution and tracking of daily production support activities, as well as provide support on a project basis. A major focus of this role is the composition and revision of technical documentation within the Packaging, Manufacturing, and Quality Departments in order to meet the company’s standards in production and quality.
Specific activities include, but are not limited to:
Author/review technical documentation including SOPs, batch records, bills of materials and work instructions.
Author Annual Product and Product Risk Process (PRP) Reviews. Collect, tabulate and analyze data for the reviews and author the reports based on the data evaluation. Ensure timely completion of the reviews.
Perform product impact / risk assessments for non-conformances, CAPAs, etc.
Investigate and author non-conformances and CAPA investigations.
Improve quality of products by utilizing data/metrics to evaluate performance, identifying and responding to improvement opportunities.
Assist in internal GMP audits and hosting GMP audits by external parties.
Develop and implement analytic tools using advanced statistical analysis of quality data to enable analysis of product performance to facilitate continuous improvement opportunities.
Compile quality metrics, identify and analyze trends and report to Quality Management.
Develop and implement intermediate to long term data-driven projects to increase process robustness.
Act as an internal consultant to various departments and teams for current interpretation of GMP/ISO/QMS.
Perform Risk Analysis as needed from daily production support activities and projects. Identify gaps in Risk Analyses and lead the cross-functional effort to fill gaps and identify appropriate risk mitigation activities.
Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed.
Provide Quality support on project work and lead projects related to core production while ensuring compliance with Design Controls and applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to identified challenges.
Challenge conventional wisdom, demonstrate innovative thought, understand risks associated with decisions and develop possible solutions which mitigate risks.
Design new Quality Systems and improve existing Quality Systems used at Cincinnati. Conduct internal audits of the Quality Systems.
Minimum of 2 years of cGMP-related commercial manufacturing experience
CAPA lifecycle experience, including root cause investigation
Presentation and communication skills
Experience with process monitoring and statistical analysis of data
Strong MS Office background (Excel, Access, Word, Project, PowerPoint, Visio, etc.)
Strong project management, planning, organizational and communication skills desired
Strong process improvement skills (process mapping, DMAIC etc.)
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
Ability to train and motivate in area of compliance and quality improvement
Self-motivated with ability to manage timely completion of long-term projects
Ability to work in a collaborative team environment
Ability to manage project priorities based on production needs
- Bachelor’s degree required in Engineering or Science
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.