Validation Analyst in Albuquerque, NM at AMRI

Date Posted: 10/27/2018

Job Snapshot

Job Description

Validation Analyst
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
Summary:
The Validations Department is responsible for formulating, reviewing and approving all validation protocols related to manufacturing or support operations.
The Validation Analyst is responsible for validation of equipment, processes, utilities, systems and components.
  • Execute validation and qualification protocols for all validated equipment, utilities, systems or processes:
  • Execute protocols for validations, documenting data for equipment, processes, utilities, systems and components. 
  • Under general supervision, conduct small to medium validation projects (projects are broken down by complexity, scope and/or duration.
    • Small projects are simple 1-2 element or test script projects featuring a single piece of equipment, component or system with a single end customer and duration of less than 1 month from commencement of initial protocol draft(s) to completion and approval of summary report.
    • Medium projects are generally more complex, with 2-5 test scripts, may include multiple pieces of equipment, components or systems with multiple end customers and duration of between 1 to 3 months from commencement of initial protocol drafts(s) to completion and approval of summary report.
    • Large projects are the most complex, requiring subject matter expertise, may contain any number of test scripts and include multiple pieces of equipment, components or systems with multiple end customers and duration of more than 3 months (from commencement of initial protocol draft to completion and approval of summary report).
  • Understand and implement safety procedures and cGMP.
  • Able to train other validation personnel in Validation Technician and Senior Technician duties.
  • Reviewing reports and documents to ensure required information is complete and accurate.
  • Participate in departmental level committees and Operational Excellence projects.
  • Be aware of changes impacting internal SOPs and notifies management and coworkers of applicable changes.
  • Keep up with pharmaceutical and regulatory publications.
  • Under general supervision, reports data using well defined formats and is able to compare data to Other duties may be assigned
Supervisory Responsibilities:                                             
This job has no supervisory responsibilities

Job Requirements

Education and/or Experience:
AS in Science/applicable degree and 2 years’ relevant experience in the industry or,
high school diploma or general education degree (GED) and six (6) years’ related experience and/or training; or equivalent combination of education and experience.
 
Language Skills:  
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills:    
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.
Computer Skills:                                                     
To perform this job successfully, an individual should have knowledge of Database software; Internet software; Spreadsheet software and Word Processing software 
 
 
 
Other Skills and Abilities:                                                  
Under direct supervision and with specific instructions, demonstrates working knowledge of internal standards for written communication as they apply to controlled document changes/revisions.
Verbally expresses ideas, facts and proposals that are clear, logical, concise and in accepted grammatical style.
Independently prepares written communications in accepted grammatical style, which need little or no editorial corrections and submit for review by supervision or a designee prior to being issued.
 
Other Qualifications:
Must pass background check
Must pass drug screen                                               

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.