QA Specialist, Aseptic Manufacturing Oversight 3rd Shift (11pm-7:30am)

About the Role

The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent operates in compliance with all applicable procedures and regulations. This role provides real-time quality oversight in aseptic manufacturing areas to ensure operations meet GMP, regulatory, and site quality standards. It delivers immediate support, promotes a strong quality culture, and partners with operations and quality staff to achieve production goals while maintaining compliance.

Responsibilities

• Perform in-person APA oversight as assigned, including gown qualification maintenance.
• Conduct APA video review, covering gowning, APA cleaning, filling room set-up, filling activities, and environmental monitoring, both live and retrospectively.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escalate major and critical observations during video review to shop-floor (live) and supervision/management (retrospective).
• Evaluate and categorize observations from video review as per procedure/protocol.
• Document video review performance and observations as per procedure/protocol.
• Assist with video review of Environmental Monitoring and Personnel Monitoring events.
• Support trending and tracking of video review observations for CAPA development.
• Assist in developing and delivering training related to aseptic manufacturing behaviors and practices.
• Review and approve deviation investigations and CAPAs.
• Participate in cross-functional project teams and collaborate with colleagues.
• Recommend improvements to procedures and processes.
• Stay informed about current good industry practices and suggest areas of improvement.
• Perform duties in accordance with company policies, SOPs, and regulatory guidelines.
• Communicate feedback constructively and perform other tasks as assigned.

Qualifications

• Bachelor’s degree in a Science or Engineering field, or equivalent experience.
• 2-5 years’ experience in the pharmaceutical industry, including aseptic manufacturing.
• Ability to maintain gown qualification for APA presence.
• Strong knowledge of Quality Systems and cGMP requirements (FDA, EU, ICH).
• Detail-oriented with high accuracy.
• Excellent verbal, written, and interpersonal communication skills.
• Effective time management, collaboration, and organizational skills.
• Ability to resolve regulatory compliance conflicts.

Pay

Expected Salary Range: $70,100 - $80,000

Benefits

American Regent offers a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401k, and other benefits.