Quality Technical Evaluator in Albuquerque, NM at AMRI

Date Posted: 5/30/2020

Job Snapshot

Job Description

Description
Quality Technical Evaluator
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.  Summary:Quality Systems is responsible for GMP compliance of the facility.  The department generates, reviews, and approves regulated, controlled documents including but not limited to SOPs, Master Batch Records, Master Packaging Records, Regulatory Filings, and Change Control Requests.  The department manages the Exception System, CAPA System, Change Control System, Quality Assurance Documentation, Regulatory Affairs, and Compliance.  Additionally, this functional group is the primary Quality contact for all external and internal customers with respect to quality systems, quality process improvements, quality audits/complaints, and regulatory compliance. Essential Duties and Responsibilities:
  • Lead GMP deviation investigations.
  • Conducts timely information gathering sessions with Manufacturing, Laboratory or Packaging/Inspection/Warehouse personnel to obtain required information and data to complete an investigation
  • Assess and document product impact within the investigation
  • Conduct thorough root cause analysis and document within the investigation including causal factors identified and any root causes determined 
  • Based on root cause outcome, identify and initiate appropriate corrective actions (CAPAs)
  • Complete accurate and thorough historical searches within deviation database to identify any similar events and determine if a trend exists or is developing.
  • Position requires technical writing capabilities to create clear, concise investigations with appropriate details.
  • Position requires knowledge of aseptic fill manufacturing operations, lyophilization and terminal sterilization processes, supporting laboratory testing, and finished product packaging and inspection processes.
  • Own CAPAs and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
  • Time management skills are essential as investigators will be required to own and manage multiple investigations or CAPAs and adhere to assigned due dates and tight timelines.
  • Ability to work independently is a must
  • Ability to work and collaborate with staff from all departments is required.
  • Knowledge of TrackWise or Master Control databases is preferred.
  • Additional responsibilities may include cross-training as a Quality Contact to close investigations from other investigators and to close other reports in multiple quality systems.
  • Participation in process improvements associated with investigation processes may be required.
  • Customer interaction for investigation related issues/questions
  • Other duties may be assigned

 Supervisory Responsibilities:  

This job has no supervisory responsibilities.


Qualifications

Education and/or Experience:

Bachelor’s degree in the Sciences and (2 to 3) years in quality assurance and/or pharmaceutical experience OR (5 to 10) years relevant experience, of which (1 to 2) years is in the pharmaceutical field. 

Computer Skills: 

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
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.

Job: Quality
Primary Location: US-NM-Albuquerque
Other Locations:
Organization: AMRI Albuquerque
Schedule: Full-time
Job Posting: Apr 30, 2020, 1:23:53 PM
Shift Type: Standard 8

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.