Allergan Patient Safety Operations Analyst (RN) in Branchburg, New Jersey

Patient Safety Operations Analyst (RN)

Branchburg, New Jersey, United States at

Jun 11, 2018Post Date

180632Requisition #

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

  • Responsible for maintaining compliance with FDA, AATB, international and state regulations during the second level quality review of all tissue donor files for tissue submitted to LifeCell to ensure the safety of donated human tissue.

  • Responsible for the triage and review of information received after initial donor release to assess the potential impact on donor suitability and distributed products, triggering escalation procedures and evaluation for regulatory action.

Main Areas of Responsibilities

  • Reviews information contained in donor files to ensure compliance with all applicable FDA and International regulations as well as AATB Standards. Utilizes clinical knowledge of acute / critical events to identify missing or ambiguous donor information to facilitate comprehensive review of donor file. Proactively identifies areas for improvements as related to donor file review and donor review metrics and implements change.

  • Reviews information received after donor release by the Medical Director in order to assess the impact on donor suitability and potential nonconforming product in distribution. Notifies compliance and assists with evaluation for field action when appropriate. Appropriately places human tissue products in quarantine as needed. Actively participates in human tissue recall activities at the direction of Quality Compliance.

  • Participates in

  • data department metrics

  • audit support as requested

  • supporting other departments as requested

  • educational workshops and orientation as requested

  • assisting with reviewing, revising and revision of SOPs as requested.

  • Coach and mentor documentation specialists as needed.


  • Understanding & Recognizing (but not limited) the following:

  • physical assessment findings

  • history & physical reports

  • death summaries / autopsies

  • diagnostic values in Electronic Medical Records (EMRs)

  • progress notes

  • flow sheets

  • other EMRs

  • IV fluids & medications

  • abnormal vital signs

Preferred Skills/Qualification

  • Basic data analysis and statistical analysis

  • Excellent interpersonal skills

  • Computer literate in MS Outlook, Word, Excel and SAP

  • Good writing, verbal and presentation abilities

  • Thinks analytically and acts decisively

  • Ability to prioritize work and meet deadlines

  • Ability to work independently

  • Ability to work as a member of a team

  • At least seven (7) years of recent (within one year) experience as an RN on an acute/critical care unit, organ donation/transplant unit or in tissue/blood banking.

  • CTBS Certified or willing to obtain within two (2) years


  • RN license with BSN or BS in Life Science (10+ years of recent {within one year} experience as an RN can be substituted for BSN/BS degree).

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.