Allergan Quality Engineer III in Branchburg, New Jersey

Quality Engineer III

Branchburg, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/6070/other-jobs-matching/location-only

Jul 23, 2018Post Date

181797Requisition #

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.

Position Overview

The Quality Engineer III will be responsible for the execution and tracking of daily production support activities regarding all aspects of product quality as well as provide support on site projects.

Main Areas of Responsibilities

Perform product impact / risk assessments for nonconformances, CAPAs, ECOs. Etc.

  • Act as in internal consultant to various departments and teams for current interpretation of GMP/ISO/QMS.

  • Review equipment validations to support ad-hoc limited qualifications, new equipment qualifications, equipment and facility requiring re-qualifications, calibrations, etc. Ensure appropriate qualifications activities are performed and documented in compliance with GMPs, GTPs, and GDPs. Review and approve validation documents in BRAM system, including remote off-shift review as required.

  • Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.

  • 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.

  • Coordinate/Schedule resources for NCR/CAPA/ECO support to ensure QE review and input.

  • 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 protocol designs.

  • Challenge conventional wisdom, demonstrate innovative thought, understand risks associated with decisions and develop possible solutions which mitigate risks.

  • Provide guidance and direction on NCR and CAPA investigations. Complete NCRs, CAPAs, and ECOs as required.

  • Recommend enhancements / continuous improvements to the Quality Management System and QMS procedures.

Minimum Requirements

The following listed requirements need to be met at a minimum level to be considered for the job:

  • Support Risk Management Activities: Update existing risk analyses as needed from Non-conformance Reports, Complaints, Sr. QE projects, etc.

  • Review and approve validation documents in BRAM system, including remote off-shift review as required.

  • Complete CAPAs/NCR’s/ECO’s as required.

  • Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.

  • 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 protocol designs.

  • Perform product impact / risk assessments for nonconformances, CAPAs, ECOs. Etc.

  • Recommend enhancements / continuous improvement of the QMS.

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.