Specialist, Quality – Amazon Store

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