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Quality Assurance Specialist I

AMRI Burlington Full-Time
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Quality Assurance Specialist I in Burlington, MA

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

The QA Specialist I 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.



Responsibilities
  • 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




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

  • 3+ 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

Recommended skills

Product Quality Assurance
Pharmaceuticals
Manufacturing
Operations
Process Engineering
Management
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Job ID: 1002653

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Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization with more than twenty years’ experience in providing customers with fully integrated drug discovery, development, and manufacturing partnerships. AMRI builds its expert knowledge and advice into customers’ programs to deliver a complete range of value-added services with more informed decision-making, resulting in enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI’s smarter options for insourcing and outsourcing support discovery and development of pharmaceutical products, manufacturing of API and drug product for existing and experimental new drugs. With unrivalled project management and locations in the United States, Europe, and Asia, AMRI maintains geographic proximity and seamless delivery across multiple sites. AMRI has historically leveraged its drug discovery expertise to progress several internal programs to the development candidate stage and, in some cases, into Phase I clinical development. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.

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