Technical Deviation Writer in Albuquerque, NM at AMRI

Date Posted: 11/3/2018

Job Snapshot

Job Description

Technical Deviation Writer

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

Summary:
The Technical Deviation Writer will assist with ensuring compliance with cGMPs, company, customer and regulatory quality standards according to requirements.  Specifically, the Technical Deviation Writer will be responsible for writing, reviewing, and/or approving investigations to ensure compliance with established standards. The quality systems investigations include but are not limited to, deviations, customer complaints, COTs, EM-viable, EM non-viable and OOS.
Essential Duties and Responsibilities:
  • Participates in the deviation, change control, complaint handling, and CAPA systems at the site.  This entails ensuring that the processes, their respective procedures and their use meet current regulatory expectations and industry best practice.
  • As Super User for TrackWise/Stratus, the Technical Deviation Writer works closely with System Administrators, Users and IT to ensure the system is used as intended.  The Technical Deviation Writer is one of the subject matter expert in the processes facilitated by the TrackWise/Stratus investigation management system.
  • Participates and/or leads investigation teams to ensure all events are thoroughly documented and the appropriate CAPAs are identified.
  • Uses appropriate tools to compile, track, trend, analyze and report key performance indicators and metrics in order to identify areas of non-compliance, best practice and improvement opportunities. 
  • Prepares information related to the state of the QMS to be used in routine monthly reporting and Quality Council meetings.
  • Proactively, based on data analysis, recommends to management areas of improvement within the various operations.
  • Participates in self-development activities to stay current with regulatory expectations and industry best practices in quality systems investigations.
  • Exhibit safety awareness and safe work practices.
  • Other duties as assigned.
Supervisory Responsibilities:  
This position has no supervisory responsibilities

Job Requirements

Education and/or Experience
  • BS preferably in Science or a related field.
  • Three years industrial GMP experience in an FDA-regulated pharmaceutical environment.
  • Proficient in Microsoft Excel, Word, PowerPoint
  • Basic quality tools (i.e. pareto charts, histograms, cause-and-effect, root cause analysis)
Language/Communication Skills
Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations.  Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures.  
 
Mathematical Skills
Ability to calculate formulas and amounts such as: concentration, percentage, area, volume, and proportion.  Ability to apply the mathematical concepts from algebra and geometry.

Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

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AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.