Aseptic Manufacturing QA Lead — Real-Time Oversight

americanregent; Shirley (NY); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Healthcare benefits

Life insurance

Profit sharing

Paid time off

401k matching

Job summary

American Regent is seeking a QA Specialist for Aseptic Manufacturing Oversight to ensure GMP and regulatory compliance in aseptic areas. You will monitor practices, perform video reviews, and guide operators on aseptic behavior.

The role requires gown qualification maintenance, collaboration with operations and quality staff, and participation in training and investigations to support CAPA development and continuous improvement.

Qualifications

• Excellent verbal, written, and interpersonal communication skills.
• Effective time management and collaboration skills.
• Strong organizational skills, planning skills and must work effectively within teams.

Responsibilities

• Perform in person APA oversight as assigned. Requires gown qualification maintenance.
• Perform APA video review, including but not limited to, gowning, APA cleaning, filling room set-up, filling activities, and environmental monitoring. Video review may be required to be performed live or retrospectively.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escape major and critical observations identified during video review to shop-floor immediately in case of live video review, and to supervision/management for retrospective video review.
• Evaluate and appropriately categorize observations from video review as per procedure and/or protocol.
• Document video review performance and observations as per procedure and/or protocol.
• Assist with video review of Environmental Monitoring and Personnel Monitoring events, as assigned.
• Assist with trending and tracking of video review observations to aid in CAPA development.
• Assist with development and delivering training related to aseptic manufacturing behaviors and practices.
• Review and approval of deviation investigations and CAPAs.
• Actively Participate in cross-functional project teams.

Skills

Verbal communication

Written communication

Interpersonal skills

Time management

Collaboration

Organizational skills

Planning

Education

Bachelor's degree in Science or Engineering

Job description

American Regent is seeking a QA Specialist for Aseptic Manufacturing Oversight to ensure GMP and regulatory compliance in aseptic areas. You will monitor practices, perform video reviews, and guide operators on aseptic behavior.

The role requires gown qualification maintenance, collaboration with operations and quality staff, and participation in training and investigations to support CAPA development and continuous improvement.