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Analytical Data Reviewer in Grafton, WI at AMRI

Date Posted: 4/18/2019

Job Snapshot

Job Description



ANALYTICAL DATA REVIEWER in Grafton, WI



 

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Analytical Data Reviewer is an integral part of the AMRI team, contributing to our success by ensuring that our products meet all specifications before being released to the customer through raw material testing, method development, validation, equipment calibrations, environmental monitoring, stability testing and final product testing. 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.



 



      

In this role, you will:                                                                                                                                                                                                                                                 



       

•       Review analytical data and documentation for compliance with cGMPs, AMRI SOPs and other written procedures; primarily chromatographic data, but also instrumental testing and wet chemistry such as water analysis, USP/EP testing, and others as required. 



•       Identify data trends, atypical results, and communicate issues for potential investigation to management as necessary.

•       Communicate with analytical scientists, supervisors, and management on technical issues, investigations, and process improvements. 

•       Identify improvements for established systems.

•       Manage timelines and multiple projects: Interface with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times.  Adjusting priorities based on due dates and invoicing goals.

•       Review and approve test methods, SOPs, forms, and other documents as necessary.

            


Job Requirements







Qualifications and background to be successful in this role:

Required

•       Bachelor’s or Master’s Degree with major in Natural Science or Pharmacy, or equivalent industrial experience

•       Experience with analytical techniques including but not limited to chromatography

•       cGMP

•       Experience or knowledge of  compendia’s such as USP/EP/BP/JP

•       Chemical Hygiene training

•       1-2 years’ experience in a Quality Control Laboratory.

•       Ability to perform complex calculations on a regular basis and comfortable communicating complex data to others.

•       Ability to efficiently base decisions on numerical data and communicate this data in easily understood formats.

•       Ability to maintain effective time management skills when making decisions.

•       Ability to be medically cleared to use a respirator by a physician

 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.





Shift:  First Shift

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.