Allergan Quality Investigator II in Branchburg, New Jersey

Quality Investigator II

Branchburg, New Jersey, United States at

Oct 10, 2018Post Date

183555Requisition #

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

Works with the Production, Quality, IT, Research & Development, Supply Chain, Planning and Engineering Departments to provide technical support to Operations in the areas listed below.

Main Areas of Responsibilities

This position is responsible for:

  • Non-conformances: Populates non-conformances to ensure records are factually written, accurately portray the event and properly investigation the non-conformance to reach probable root cause when possible. Lead cross-functional teams when appropriate to investigate more complex quality events. Electronic systems: Perform activities within the electronic CAPA system (TrackWise®). Utilize the (SAP®) database to review electronic batch entries.

  • Corrective Actions/Preventive Actions (CAPA): Ensure that corrective actions are properly investigated for the elimination of root cause and prevent reoccurrence. Ensure that all actions are verified and/or validated. Ensure that actions do not adversely impact finished devices. Develop new documents, or revise current documents, and implement Engineering Change Orders (ECOs).

  • NCR/CAPA System Metrics: Assist in the NCR/CAPA system data collection, interpretation and documentation to support all system metrics (monthly, quarterly, and ad hoc report needs) on a timely basis.

  • Partners with Production line management and Operations Departments to identify potential quality problems, to identify possible process efficiency improvements, and to troubleshoot production problems.

  • Trains more junior Quality Investigators to ensure records are complete, accurate and submitted in a timely manner. Other duties as assigned (e.g. may work with the Supply Chain group on inventory and supply issues, with Facilities to support construction, modifications, or repairs in the Production areas, with Operations Engineering and Development to implement new equipment/processes or to modify current equipment/processes or with IT to trouble shoot problems and assist with new software implementation, executing test cases as necessary). Assists with the yearly review of all production documents for accuracy and completeness.

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

  • High School/Secondary School/Equivalent required.

  • Without degree – A minimum of 5 years cleanroom, Production or Packaging

  • Technical Support to Operations, or in Quality Control/Quality Assurance

  • Bachelor’s degree in Engineering or Science related discipline is preferred.

  • With degree - A minimum of 3 years cleanroom, Production or Packaging

  • Technical Support to Operations, or in Quality Control/Quality Assurance

  • Experience in leading investigations and CAPA activities.

  • Experience in quality improvement processes, quality systems and tools.

  • Knowledge of regulatory agency requirements Experience with quality systems

  • Experience with FDA Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

  • Computer literate: Microsoft Word, Microsoft Excel, Microsoft PowerPoint

  • Attention to detail, and the ability to organize and prioritize multiple tasks and responsibilities

  • Ability to lead cross-functional teams to ensure timely implementation or quality records

  • Technical writing experience

  • Good analytical skills and problem-solving experience

  • Ability to learn investigative technique and project management skills

  • Meeting facilitating, communication and presentation skills

  • Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment

  • Increase the efficiency and effectiveness of the corrective and preventive action system

  • Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.

  • TrackWise® system experience preferred.

  • Non-conformance, Quality Investigation, CAPA, Internal Audit experience preferred.

  • Training experience preferred.

  • Experience with Allergan equipment, process, programs, and procedures 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.