Specialist, Quality – Amazon Store

Specialist, Quality – Amazon Store Skip to content November 11, 2025 About the position Responsibilities Perform 100% audit of process documents/log books to ensure completeness and accuracy for assigned functional area. Provide coaching and mentoring of Operations personnel regarding documentation completion. Coordinate with Operations to discuss, resolve, and eliminate documentation observations. Conduct GMP walk-through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements. Ensure proper identification of release status and control of materials through maintenance of quarantines in the SAP system. Perform Quality review/approval of new and updated SOPs and CJAs. Assist with training of incoming personnel and ensure compliance with departmental procedures. Participate in departmental communication processes to escalate concerns and best practices. Collaborate with members from other support groups to identify and implement continuous improvement initiatives. Resolve outstanding issues with process documents/log books and GMP walk-through inspection observations. Cross-train to support other functional quality areas including deviation management and inspection support. Complete training to review qualification documents, change requests, and atypical event investigations. Prioritize review of process documents/log books to maximize cycle-time efficiency. Perform SAP transactions required to document Batch Record and Critical Site review. Requirements Bachelor degree in a scientific or engineering field preferred; candidates with other majors will be considered with relevant experience. At least one year of relevant post-degree work experience in a GMP-related field, including Technical, Engineering, Quality, or Operations. Evidence of leadership skills with good verbal and written communication skills. Effectiveness and creativity in solving technical problems. Attention to detail, flexibility, and awareness of production and quality control problems. Basic understanding of cGMPs and regulatory requirements in the pharmaceutical field. Basic understanding of Microsoft applications (e.g., MS Excel, Outlook, MS Access). Flexibility to support off-shift or weekend schedules, if necessary. Nice-to-haves Familiarity with vaccine and/or pharmaceutical processing. Experience with manufacturing batch records is strongly preferred. Quality assurance audits or inspection experience in vaccine or pharmaceutical manufacturing is a strong plus. Aseptic gowning experience. Benefits Health insurance coverage Dental insurance coverage 401k retirement savings plan Paid holidays Flexible scheduling options Professional development opportunities Choosing a selection results in a full page refresh. Opens in a new window.