Senior Quality Assurance Specialist in Albany, NY at AMRI

Date Posted: 11/11/2019

Job Snapshot

Job Description

SENIOR QUALITY ASSURANCE SPECIALIST in Albany, NY


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 ensuring compliance with cGMPs,

Company and customer quality standards as well as external regulatory requirements.

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:                                                                                                                                                                                                                                                 


  • Assist in internal and external audit programs and prepare reports as required. This may include the preparation of Audit Plans, conducting audits and writing Audit reports & Audit responses.
  • Develop and maintain a thorough understanding of cGMPs and associated regulations.
  • Review and approve master and production batch records.
  • Quality system management. Review and approve deviations, investigations, change control, & CAPA. Compile data, prepare and review trends. Identify areas of concern and communicate to management.
  • Review and approve SOPs. Write SOPs as required.
  • Review and assist in resolving customer complaints.
  • Perform batch record release.
  • Assist in resolving quality problems/concerns with quality control and manufacturing personnel.



Job Requirements

Required

 

  • B.S. degree in Chemistry or related field.
  • A minimum of five years industrial cGMP experience in an FDA-regulated pharmaceutical environment.
  • Strong written communication skills including the ability to independently write complex reports, business correspondence, and procedures. Ability to read and interpret regulatory and technical documents such as FDA and ICH guidance documents, protocols, reports, and standard operating procedures.

  

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.

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.