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Quality Assurance Specialist III - 1st Shift in Burlington, MA at AMRI

Date Posted: 5/9/2019

Job Snapshot

Job Description



QUALITY ASSURANCE SPECIALIST III in Burlington, MA

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

The QA Specialist III is an integral part of the AMRI team, contributing to our success by maintaining Quality databases and providing routine on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action.

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: 
  • Responsible for working cross-functionally with Manufacturing, PRocess Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as the following:
      • Executed/Unexecuted Batch Record Review.
      • Executed/Unexecuted Validation/Facility Protocols/Reports.
      • Reviewing Change Controls.
      • Reviewing Facility Work Orders prior to filing.
  • Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP’s and AMRI’s quality system to ensure real-time compliance.
  • Represent AMRI Quality Assurance when managing issues that require immediate corrective action.  Ensure such action taken is appropriate and appropriately documented.  
  • Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
  • Monitor Operations personnel for adherence to SOP’s.  Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement


Job Requirements



Qualifications and background to be successful in this role:

Required

  • Bachelor’s degree in life science field; alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience
  • Experience in cGMP pharmaceutical/biotechnology or medical device industry

 

Preferred

  • 7-10 years' experience in Quality Assurance field, ideally supporting pharmaceutical manufacturing
  • Previous experience supporting on-the-floor activities for production facility
  • Strong facilitation and problem solving skills
  • Excellent written and verbal communication and presentation skills. Comfortable presenting information to management & peers
  • Comfortable working independently in combination with individuals in other departments across the organization



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.

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.