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Quality Control Technician II, 2nd Shift

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Quality
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184593 Requisition #
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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 Assurance Inspector is the primary daily contact for operations with the Quality Assurance group.  With limited supervision by the ManagerQuality Assurance - Inspections, the Quality Assurance Inspector independently coordinates and executes all tasks relating to inspection.  The Inspector will perform checks and audits in Packaging, Manufacturing, and/or the warehouse on a daily basis.  The Inspector has the responsibility to assess product conformity to specifications and the authority to disposition in-process materials.  When incidents occur, the Inspector will initiate and conduct investigations and coordinate activities with production personnel.

Main Areas of Responsibilities

  • The inspector is the primary day-to-day Quality Assurance contact for production personnel.
  • The inspector has the responsibility to ensure that operations are complying with cGMPs and Standard Operating Procedures.
  • The inspector is responsible for identifying deviations that occur in operations.  When deviations occur, inspectors have the authority and responsibility to stop the operation.  Additionally, inspectors have the authority to refuse the release of an operation if requirements for release have not been satisfactorily met.
  • The inspector has the responsibility to assess product conformity to specifications and the authority to disposition in-process materials.  If materials are found to be non-conforming, inspectors have the authority to segregate material and place it on QA Hold/Block. 
  • The inspector is responsible for conducting investigations.  This includes performing and overseeing investigations into failed or out of spec conditions, incomplete/incorrect documentation, deviations or incidents.
  • The inspector is responsible for assessing the adequacy of batch record documentation on-line. 
  • Daily responsibilities include review and release of production lines and rooms, line audits and checks, retain sampling, ANSI inspections, general inspection, incoming materials inspection, and resolving production problems. 
  • The Quality Assurance inspector is responsible for conducting materials tracking for re-assay, sampling, and inspection.
  • The Quality Assurance inspector also authors and reviews Standard Operating Procedures, generates cGMP documentation, and provides training as needed to other employees.
  • Handles additional responsibilities and projects that may be assigned by immediate supervision or other QA Management staff.  Possess the latitude to decide how to best complete assigned projects and responsibilities. 
  • Each employee will be required to develop their individual skills to a point that will allow them to train others.
  • Perform documentation support – ensures compliance with SOP’s, Batch Records, Validation Reports, Forms, Training and Visual Inspection Reports (VIR).
  • Perform room/equipment inspections (Production) – Assessing whether the proper clean was done and documented as required. Assessing that the cleaning was performed satisfactorily per SOP (prevent cross contamination).
  • Assist with Current Good Manufacturing Practice (cGMP) training for new employees when necessary.
  • Conduct Quarterly Environmental Monitoring (EM) – independently coordinating the sampling of facilities and equipment, interpreting the data, assessing if the facility is acceptable for the processing of drug products based on the data gathered and summarizing the information in a report.  
  • Investigate Customer Complaints (CC).
  • Review and approve the calibrations program reports and paperwork.  Reviews calibration and preventative maintenance stickers prior to releasing equipment for production.
  • Review and approval of various procedures, production, and documentation as directed in SOP’s.
  • Conducts self-inspection audits to ensure compliance with Quality Management System procedures and cGMP regulations.

Requirements

  • This is an entry level professional position for Quality Assurance. 
  • No specific experience is required but Pharmaceutical Industry experience is preferred.

Preferred Skills/Qualification

  • Incumbents should be thorough, detail-oriented, have the ability to multi-task and possess strong organizational and communication skills.
  • The position requires proficiency in basic mathematics and the ability to read and interpret written instruction and data, and proficiency in the use of Microsoft Word, Excel, Access, PowerPoint, Outlook and Internet Explorer.
  • Some technical writing experience is preferred.
  • The Quality Assurance inspector must have the ability to work well with others and be a team player. 
  • Each Quality Assurance inspector will be required to train, coach and coordinate with others throughout the plant.
  • The Quality Assurance inspector must possess excellent communication skills to adequately communicate with departments within the plant. 
  • The communication ability also extends outside the plant to persons within the Forest/Allergan organization, vendors, and any other outside contacts. 

Education

  • A bachelor’s degree is preferred, and scientific discipline is preferred.  Other educational disciplines and industry experience will be considered.

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.

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