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The QA Specialist is responsible for 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 executed/unexecuted batch record review, executed/unexecuted validation/facility protocols/reports, reviewing change controls, and 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

• Bachelor’s Degree in Life Science or related field required
• 1+ years of experience in Quality Assurance supporting manufacturing in Pharmaceutical, Biotechnology or Medical Device industry preferred
• Previous experience supporting on-the-floor activities for production facility preferred

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