Senior Quality Assurance Specialist in Lebanon, NJ at AMRI

Date Posted: 9/24/2019

Job Snapshot

Job Description


SENIOR QUALITY ASSURANCE SPECIALIST in Lebanon, NJ


 

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

The Senior Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by developing and implementing the company’s quality systems (cGMP’s & ISO 17025) and ensuring that all testing work completed by the laboratory is in accordance with client specifications, the company’s standard operating procedures and regulatory agencies regulations.

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:                                                                                                                                                                                                                                                 


                             

•       Assure that all quality related records generated by the company adhere to a strict review process insuring the integrity of the final report of analysis being in compliance with all regulatory and company standards.

•       Maintain the company’s training program assuring that all personnel receive adequate training to perform their job functions in accordance to the cGMPs.               

        Maintain the company’s IQ, OQ, PQ, PV and PM program for all Laboratory measurement and test equipment.

•       Coordinate and respond to client quality questionnaires.

•       Schedule and host Client Audits and internal audits.

•       Prepare audit responses and follow-up

•       Support Data Review and final sign off on analytical reports and back-up to the QA Associate.

•       Review and revise SOPs.

•       Monitor, review and approve laboratory investigations and corrective and preventative actions to completion.

•         Other duties and responsibilities may be required as needed.  

Job Requirements



Qualifications and background to be successful in this role:

 

•       A college degree is required with a major in science preferred.

•       Prior QA and Laboratory experience with a comprehensive understanding and working knowledge of the cGMP’s is a must.

•       Good grammar and written/oral communication skills are required as well as being detailed oriented.

 

 

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:  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.